Ziprasidone Hydrochloride: Package Insert and Label Information (Page 7 of 7)

Ziprasidone Capsules, USP 40 mg — Container Label

Container2
(click image for full-size original)

Ziprasidone Capsules, USP 60 mg — Container Label

Container3
(click image for full-size original)

Ziprasidone Capsules, USP 80 mg — Container Label

Container4
(click image for full-size original)
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-835
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ziprasidone hydrochloride (ziprasidone) ziprasidone 20 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose
magnesium stearate
polysorbate 80
povidone k30
starch, corn
silicon dioxide
FD&C BLUE NO. 1
FD&C RED NO. 3
gelatin
ferric oxide red
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
shellac
ammonia
Product Characteristics
Color PURPLE (Lavender opaque cap and flesh opaque body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RDY;256
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-835-01 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077565 07/26/2018
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-836
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ziprasidone hydrochloride (ziprasidone) ziprasidone 40 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose
magnesium stearate
polysorbate 80
povidone k30
starch, corn
silicon dioxide
FD&C BLUE NO. 1
FD&C RED NO. 3
gelatin
ferric oxide red
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
shellac
ammonia
Product Characteristics
Color PURPLE (Lavender opaque cap and LT turquoise blue opaque body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-836-01 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077565 07/26/2018
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-837
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ziprasidone hydrochloride (ziprasidone) ziprasidone 60 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose
magnesium stearate
polysorbate 80
povidone k30
starch, corn
silicon dioxide
FD&C BLUE NO. 1
FD&C RED NO. 3
gelatin
ferric oxide red
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
shellac
ammonia
Product Characteristics
Color BROWN (Flesh opaque cap and Flesh opaque body) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code RDY;258
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-837-01 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077565 07/26/2018
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-838
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ziprasidone hydrochloride (ziprasidone) ziprasidone 80 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose
magnesium stearate
polysorbate 80
povidone k30
starch, corn
silicon dioxide
FD&C BLUE NO. 1
FD&C RED NO. 3
gelatin
ferric oxide red
titanium dioxide
ferrosoferric oxide
butyl alcohol
alcohol
isopropyl alcohol
potassium hydroxide
propylene glycol
shellac
ammonia
Product Characteristics
Color BLUE (LT Turquoise blue opaque cap and Flesh opaque body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code RDY;259
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-838-01 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077565 07/26/2018
Labeler — NorthStar Rx LLC (830546433)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited — FTO 3 918608162 analysis (16714-835), manufacture (16714-835), analysis (16714-836), manufacture (16714-836), analysis (16714-837), manufacture (16714-837), manufacture (16714-838), analysis (16714-838)

Revised: 02/2022 NorthStar Rx LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

https://druginserts.com/lib/rx/meds/ziprasidone-hydrochloride-5/page/7/

Clinical Trials

DrugInserts.com

Information Sections

RSS Feeds

About

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.