ChlorproMAZINE Hydrochloride: Package Insert and Label Information (Page 3 of 3)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 63304-185-01

ChlorproMAZINE Hydrochloride Tablets, USP

10 mg

Rx only

100 Tablets

SUN PHARMA

spl-chlorpromazine-label1
(click image for full-size original)

NDC 63304-143-01

ChlorproMAZINE Hydrochloride Tablets, USP

25 mg

Rx only

100 Tablets

SUN PHARMA

spl-chlorpromazine-label2
(click image for full-size original)

NDC 63304-122-01

ChlorproMAZINE Hydrochloride Tablets, USP

50 mg

Rx only

100 Tablets

SUN PHARMA

spl-chlorpromazine-label3
(click image for full-size original)

NDC 63304-114-01

ChlorproMAZINE Hydrochloride Tablets, USP

100 mg

Rx only

100 Tablets

SUNPHARMA

spl-chlorpromazine-label4
(click image for full-size original)

NDC 63304-083-01

ChlorproMAZINE Hydrochloride Tablets, USP

200 mg

Rx only

100 Tablets

SUN PHARMA

spl-chlorpromazine-label5
(click image for full-size original)
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine tablet, sugar coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-185
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GLYCERYL MONOSTEARATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SUCROSE
TALC
Product Characteristics
Color RED Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 509
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-185-01 100 TABLET, SUGAR COATED in 1 BOTTLE None
2 NDC:63304-185-10 1000 TABLET, SUGAR COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214256 11/18/2020
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine tablet, sugar coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-143
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GLYCERYL MONOSTEARATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SUCROSE
TALC
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 510
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-143-01 100 TABLET, SUGAR COATED in 1 BOTTLE None
2 NDC:63304-143-10 1000 TABLET, SUGAR COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214256 11/18/2020
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine tablet, sugar coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-122
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GLYCERYL MONOSTEARATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SUCROSE
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 511
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-122-01 100 TABLET, SUGAR COATED in 1 BOTTLE None
2 NDC:63304-122-10 1000 TABLET, SUGAR COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214256 11/18/2020
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine tablet, sugar coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-114
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GLYCERYL MONOSTEARATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SUCROSE
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 512
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-114-01 100 TABLET, SUGAR COATED in 1 BOTTLE None
2 NDC:63304-114-10 1000 TABLET, SUGAR COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214256 11/18/2020
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine tablet, sugar coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-083
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GLYCERYL MONOSTEARATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SUCROSE
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 513
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-083-01 100 TABLET, SUGAR COATED in 1 BOTTLE None
2 NDC:63304-083-10 1000 TABLET, SUGAR COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214256 11/18/2020
Labeler — Sun Pharmaceutical Industries Inc (146974886)
Registrant — Sun Pharmaceutical Industries Inc (146974886)
Establishment
Name Address ID/FEI Operations
Aizant Drug Research Solutions Pvt. Ltd. 650372951 MANUFACTURE (63304-185), MANUFACTURE (63304-143), MANUFACTURE (63304-122), MANUFACTURE (63304-114), MANUFACTURE (63304-083)

Revised: 11/2020 Sun Pharmaceutical Industries Inc

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