Temozolomide: Package Insert and Label Information (Page 5 of 5)

Temozolomide Capsules

PHARMACIST: Dispense enclosed Patient Package Insert to each patient.

PHARMACIST INFORMATION SHEET

IMPORTANT DISPENSING INFORMATION

For every patient, dispense temozolomide capsules in a separate vial or in its original package making sure each container lists the strength per capsule and that patients take the appropriate number of capsules from each package or vial.

What is temozolomide capsule? [see Full Prescribing Information, Indications and Usage (1)] .

Temozolomide is an oral alkylating agent for the treatment of newly diagnosed glioblastoma multiforme and refractory anaplastic astrocytoma.

How is temozolomide capsules dosed? [see Full Prescribing Information, Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma (2.1) , Recommended Dosage and Dosage Modifications for Refractory Anaplastic Astrocytoma (2.2)] .

The physician calculates the daily dose of temozolomide capsules for a given patient based on the patient’s body surface area (BSA). Round off the resulting dose to the nearest 5 mg. An example of the dosing may be as follows: the initial daily dose of temozolomide capsules in milligrams is the BSA multiplied by mg/m 2 /day,(e.g., a patient with a BSA of 1.84 is 1.84 x 75 mg = 138, or 140 mg/day). Adjust the dose for subsequent cycles according to nadir neutrophil and platelet counts in the previous cycle and at the time of initiating the next cycle.

How might the dose of temozolomide capsules be modified for Refractory Anaplastic Astrocytoma? [see Full Prescribing Information, Recommended Dosage and Dosage Modifications for Refractory Anaplastic Astrocytoma (2.2)] .

The initial dose is 150 mg/m 2 orally once daily for 5 consecutive days per 28-day treatment cycle. Increase the temozolomide capsules dose to 200 mg/m 2 /day for 5 consecutive days per 28-day treatment cycle if both the nadir and day of dosing (Day 29, Day 1 of next cycle) absolute neutrophil counts (ANC) are greater than or equal to 1.5 x 10 9 /L (1500/μL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 x 10 9 /L (100,000/μL). During treatment, obtain a complete blood count on Day 22 (21 days after the first dose) and weekly until the ANC is above 1.5 x 10 9 /L (1500/μL) and the platelet count exceeds 100 x 10 9 /L (100,000/μL). Do not start the next cycle of temozolomide capsules until the ANC and platelet count exceed these levels. If the ANC falls to less than 1.0 x 10 9 /L (1000/μL) or the platelet count is less than 50 x 10 9 /L (50,000/μL) during any cycle, reduce the dose for the next cycle

Table 1
(click image for full-size original)

by 50 mg/m 2. Permanently discontinue temozolomide capsules in patients who are unable to tolerate a dose of 100 mg/m 2 per day.

Patients should continue taking temozolomide capsules until their physician determines that their disease has progressed or until unacceptable side effects or toxicities occur. In the clinical trial, treatment could be continued for a maximum of 2 years, but the optimum duration of therapy is not known. Physicians may alter the treatment regimen for a given patient.

Dosing for Patients with Newly Diagnosed Glioblastoma Multiforme [see Full Prescribing Information, Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma (2.1)] .

Concomitant Phase Treatment Schedule

Administer temozolomide capsules orally at 75 mg/m 2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions), followed by maintenance temozolomide capsules for 6 cycles. No dose reductions are recommended; however, dose interruptions may occur based on patient tolerance. Continue the temozolomide capsules dose throughout the 42 day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count greater than or equal to 1.5 x 10 9 /L, platelet count greater than or equal to 100 x10 9 /L, and nonhematological adverse reactions less than or equal to Grade 1 (except for alopecia, nausea and vomiting).During treatment,obtain a complete blood count weekly. Interrupt or discontinue temozolomide dosing during the concomitant phase according to the hematological and nonhematological toxicity criteria [see Table 1 in the Full Prescribing Information, Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma (2.1)]. Pneumocystis pneumonia (PCP) prophylaxis is required during the concomitant administration of temozolomide capsules and radiotherapy, and should be continued in patients who develop lymphocytopenia until resolution to Grade 1 or less.

Maintenance Phase Treatment Schedule

Four weeks after completing the temozolomide capsules and radiotherapy phase, administer temozolomide capsules for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m 2 once daily for 5 days followed by 23 days without treatment. At the start of Cycle 2, escalate the dose to 200 mg/m 2 , if the nonhematologic adverse reactions for Cycle 1 are Grade less than or equal to 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is greater than or equal to 1.5 x 10 9 /L, and the platelet count is greater than or equal to 100 x 10 9 /L. If the dose was not escalated at Cycle 2, do not escalate the dose in subsequent cycles. Maintain the dose at 200 mg/m 2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.

During treatment, obtain a complete blood count on Day 22 (21 days after the first dose) and weekly until the ANC is above 1.5 x 10 9 /L (1500/μL) and the platelet count exceeds 100 x 10 9 /L (100,000/μL). Do not start the next cycle of temozolomide capsules until the ANC and platelet count exceed these levels. Base dose reductions during the next cycle on the lowest blood counts and worst nonhematologic adverse reactions during the previous cycle. Apply dose reductions or discontinuations during the maintenance phase [see Table 2 in the Full Prescribing Information, Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma (2.1) ] .

How is temozolomide capsules taken? [see See Full Prescribing Information, Preparation and Administration, Temozolomide capsules (2.3) ] .

Advise patients to take each day’s dose with a full glass of water, preferably on an empty stomach or at bedtime. Taking the medication on an empty stomach or at bedtime may help ease nausea. If patients are also taking anti-nausea or other medications to relieve the side effects associated with temozolomide capsules, advise them to take these medications prior to and/or following administration of temozolomide capsules. Advise patients that temozolomide capsules should be swallowed whole and NEVER CHEWED. Advise patients that they SHOULD NOT open or split the capsules. If capsules are accidentally opened or damaged, advise patients to take rigorous precautions with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. In case of powder contact, advise the patients to wash their hands. Advise patients to keep this medication away from children

What should the patient avoid during treatment with temozolomide capsules? [see Full Prescribing Information, Use in Specific Populations, Pregnancy (8.1) , Lactation (8.2) , Females and Males of Reproductive Potential (8.3) ]

There are no dietary restrictions for patients taking temozolomide capsules. Temozolomide capsules may affect testicular function and may cause birth defects. Advise male patients to exercise adequate birth control measures. Advise female patients to avoid becoming pregnant while receiving this drug. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose. Advise males of reproductive potential to use condoms during treatment and for at least 3 months after the last dose. Advise male patients not to donate semen during treatment with temozolomide capsules and for at least 3 months after the final dose. It is not known whether temozolomide is excreted into breast milk. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed while taking temozolomide capsules and for at least 1 week after the last dose.

What are the side effects of temozolomide capsules? [see Full Prescribing Information, Adverse Reactions (6) . ]

Alopecia, fatigue, nausea, and vomiting are the most common side effects associated with temozolomide capsules. Noncumulative myelosuppression is the dose-limiting toxicity. Patients should be evaluated periodically by their physician to monitor blood counts.

Other commonly reported side effects reported by patients taking temozolomide capsules are headache, constipation, anorexia, and convulsions.

How is temozolomide capsules supplied? [see Full Prescribing Information, How Supplied/Storage and Handling (16) . ]

Temozolomide capsules are available in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths. The capsules contain a white capsule body with a color cap, and the colors vary based on the dosage strength.

Temozolomide Capsule StrengthColor
5 mgGreen Cap
20 mgYellow Cap
100 mgPink Cap
140 mgTransparent Blue Cap
180 mgMaroon Cap
250 mgWhite Cap

The 5-mg, 20-mg, 100-mg, 140-mg, and 180-mg capsule strengths are available in 5 count and 14 count packages. The 250-mg capsule strength is available in 5 count package.

How is temozolomide capsules dispensed?

Dispense each strength of temozolomide capsules in a separate vial or in its original package (one strength per one container). Follow the instructions below:

Based on the dose prescribed, determine the number of each strength of temozolomide capsules needed for the full 42-or 5-day cycle as prescribed by the physician. For example, in a 5-day cycle, 275 mg/day would be dispensed as five 250-mg capsules, five 20-mg capsules and five 5-mg capsules. Label each container with the appropriate number of capsules to be taken each day. Dispense to the patient, making sure each container lists the strength (mg) per capsule and that he or she understands to take the appropriate number of capsules of temozolomide capsules from each package or vial to equal the total daily dose prescribed by the physician.

How can temozolomide capsules be ordered?

Temozolomide capsules can be ordered from your wholesaler. It is important to understand if temozolomide capsules are being used as part of a 42-day regimen or as part of a 5-day course. Remember to order enough temozolomide capsules for the appropriate cycle. For example:

  • a 5-day course of 360 mg/day would require the following to be ordered: two 5-count packages of 180-mg capsules.
  • a 42-day course of 140 mg/day would require the following to be ordered: three 14-count packages of 140-mg capsules.
Temozolomide Capsules NDC Number
Amber Glass Bottles:
5-mg capsules (5 count)16729-048-53
5-mg capsules (14 count) 16729-048-54
20-mg capsules (5 count) 16729-049-53
20-mg capsules (14 count) 16729-049-54
100-mg capsules (5 count)16729-050-53
100-mg capsules (14 count)16729-050-54
140-mg capsules (5 count) 16729-129-53
140-mg capsules (14 count)16729-129-54
180-mg capsules (5 count) 16729-130-53
180-mg capsules (14 count) 16729-130-54
250-mg capsules (5 count) 16729-051-53
Sachet Packs (Carton Contains Individual Sachet with One Capsule each):
5-mg capsules (5 count) 16729-048-31
5-mg capsules (14 count)16729-048-04
20-mg capsules (5 count)16729-049-31
20-mg capsules (14 count)16729-049-04
100-mg capsules (5 count)16729-050-31
100-mg capsules (14 count)16729-050-04
140-mg capsules (5 count)16729-129-31
140-mg capsules (14 count)16729-129-04
180-mg capsules (5 count)16729-130-31
180-mg capsules (14 count)16729-130-04
250-mg capsules (5 count)16729-051-31

References:
“OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.
Manufactured By:
Intas Pharmaceuticals Limited,
Ahmedabad – 380 054, India.

10 1475 4 6011995

Issued October 2021

PRINCIPAL DISPLAY PANEL

Principal Display Panel- 5 mg Capsules

Amber Glass Bottle Carton

NDC 16729- 048 -53

Temozolomide Capsules

5 mg

Rx only

5 capsules

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 20 mg Capsules

Amber Glass Bottle Carton

NDC 16729- 049 -53

Temozolomide Capsules

20 mg

Rx only

5 capsules

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 100 mg Capsules

Amber Glass Bottle Carton

NDC 16729- 050 -53

Temozolomide Capsules

100 mg

Rx only

5 capsules

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 140 mg Capsules

Amber Glass Bottle Carton

NDC 16729- 129 -53

Temozolomide Capsules

140 mg

Rx only

5 capsules

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 180 mg Capsules

Amber Glass Bottle Carton

NDC 16729- 130 -53

Temozolomide Capsules

180 mg

Rx only

5 capsules

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 250 mg Capsules

Amber Glass Bottle Carton

NDC 16729- 051 -53

Temozolomide Capsules

250 mg

Rx only

5 capsules

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 5 mg Capsules

Sachet Pack Carton

NDC 16729- 048 -31

Temozolomide Capsules

5 mg

Rx only

THIS PACKAGE CONTAINS 5 INDIVIDUAL SACHETS

Each Individual Sachet Contains One Capsule Each

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 20 mg Capsules

Sachet Pack Carton

NDC 16729- 049 -31

Temozolomide Capsules

20 mg

Rx only

THIS PACKAGE CONTAINS 5 INDIVIDUAL SACHETS

Each Individual Sachet Contains One Capsule Each

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 100 mg Capsules

Sachet Pack Carton

NDC 16729- 050 -31

Temozolomide Capsules

100 mg

Rx only

THIS PACKAGE CONTAINS 5 INDIVIDUAL SACHETS

Each Individual Sachet Contains One Capsule Each

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 140 mg Capsules

Sachet Pack Carton

NDC 16729- 129 -31

Temozolomide Capsules

140 mg

Rx only

THIS PACKAGE CONTAINS 5 INDIVIDUAL SACHETS

Each Individual Sachet Contains One Capsule Each

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 180 mg Capsules

Sachet Pack Carton

NDC 16729- 130 -31

Temozolomide Capsules

180 mg

Rx only

THIS PACKAGE CONTAINS 5 INDIVIDUAL SACHETS

Each Individual Sachet Contains One Capsule Each

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Principal Display Panel- 250 mg Capsules

Sachet Pack Carton

NDC 16729- 051 -31

Temozolomide Capsules

250 mg

Rx only

THIS PACKAGE CONTAINS 5 INDIVIDUAL SACHETS

Each Individual Sachet Contains One Capsule Each

PRINCIPAL DISPLAY PANEL
(click image for full-size original)
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-048
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMOZOLOMIDE (TEMOZOLOMIDE) TEMOZOLOMIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TARTARIC ACID
STEARIC ACID
FERRIC OXIDE RED
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color green, white Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code 5;TMZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-048-53 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-048-53)
2 NDC:16729-048-54 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
2 14 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-048-54)
3 NDC:16729-048-31 5 POUCH in 1 CARTON contains a POUCH
3 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-048-31)
4 NDC:16729-048-04 14 POUCH in 1 CARTON contains a POUCH
4 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-048-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201528 03/07/2017
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-049
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMOZOLOMIDE (TEMOZOLOMIDE) TEMOZOLOMIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
STEARIC ACID
FERRIC OXIDE RED
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
ANHYDROUS LACTOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TARTARIC ACID
Product Characteristics
Color yellow, white Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code 20;TMZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-049-53 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-049-53)
2 NDC:16729-049-54 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
2 14 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-049-54)
3 NDC:16729-049-31 5 POUCH in 1 CARTON contains a POUCH
3 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-049-31)
4 NDC:16729-049-04 14 POUCH in 1 CARTON contains a POUCH
4 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-049-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201528 03/07/2017
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-050
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMOZOLOMIDE (TEMOZOLOMIDE) TEMOZOLOMIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TARTARIC ACID
STEARIC ACID
FERRIC OXIDE RED
GELATIN
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color pink, white Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code 100;TMZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-050-53 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-050-53)
2 NDC:16729-050-54 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
2 14 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-050-54)
3 NDC:16729-050-31 5 POUCH in 1 CARTON contains a POUCH
3 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-050-31)
4 NDC:16729-050-04 14 POUCH in 1 CARTON contains a POUCH
4 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-050-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201528 03/07/2017
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-129
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMOZOLOMIDE (TEMOZOLOMIDE) TEMOZOLOMIDE 140 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TARTARIC ACID
STEARIC ACID
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color blue, white Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code 140;TMZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-129-53 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-129-53)
2 NDC:16729-129-54 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
2 14 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-129-54)
3 NDC:16729-129-31 5 POUCH in 1 CARTON contains a POUCH
3 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-129-31)
4 NDC:16729-129-04 14 POUCH in 1 CARTON contains a POUCH
4 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-129-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201528 03/07/2017
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-130
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMOZOLOMIDE (TEMOZOLOMIDE) TEMOZOLOMIDE 180 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TARTARIC ACID
STEARIC ACID
FERRIC OXIDE RED
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color orange (maroon) , white Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code 180;TMZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-130-53 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-130-53)
2 NDC:16729-130-54 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
2 14 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-130-54)
3 NDC:16729-130-31 5 POUCH in 1 CARTON contains a POUCH
3 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-130-31)
4 NDC:16729-130-04 14 POUCH in 1 CARTON contains a POUCH
4 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-130-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201528 03/07/2017
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-051
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMOZOLOMIDE (TEMOZOLOMIDE) TEMOZOLOMIDE 250 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TARTARIC ACID
STEARIC ACID
GELATIN
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color white, white Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code 250;TMZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-051-53 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (16729-051-53)
2 NDC:16729-051-31 5 POUCH in 1 CARTON contains a POUCH
2 1 CAPSULE in 1 POUCH This package is contained within the CARTON (16729-051-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201528 03/07/2017
Labeler — Accord Healthcare Inc. (604222237)
Registrant — Accord Healthcare Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 manufacture (16729-048), manufacture (16729-049), manufacture (16729-050), manufacture (16729-129), manufacture (16729-130), manufacture (16729-051), analysis (16729-048), analysis (16729-049), analysis (16729-050), analysis (16729-129), analysis (16729-130), analysis (16729-051)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 915837971 manufacture (16729-048), manufacture (16729-049), manufacture (16729-050), manufacture (16729-129), manufacture (16729-130), manufacture (16729-051), analysis (16729-048), analysis (16729-049), analysis (16729-050), analysis (16729-129), analysis (16729-130), analysis (16729-051)

Revised: 01/2022 Accord Healthcare Inc.

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