PITAVASTATIN CALCIUM tablet

pitavastatin calcium by

Drug Labeling and Warnings

pitavastatin calcium by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pitavastatin Tablets, 1 mg

NDC: 70771-1784-9

Bottle of 90 tablets

Rx only

Pitavastatin Tablets, 2 mg

NDC: 70771-1785-9

Bottle of 90 tablets

Rx only

Pitavastatin Tablets, 4 mg

NDC: 70771-1786-9

Bottle of 90 tablets

Rx only

INGREDIENTS AND APPEARANCE

PITAVASTATIN CALCIUM 
pitavastatin calcium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1784
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P)	PITAVASTATIN	1 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM CARBONATE (UNII: 45P3261C7T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	481
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1784-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206047	11/02/2023

PITAVASTATIN CALCIUM 
pitavastatin calcium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1785
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P)	PITAVASTATIN	2 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM CARBONATE (UNII: 45P3261C7T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	482
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1785-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206047	11/02/2023

PITAVASTATIN CALCIUM 
pitavastatin calcium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1786
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P)	PITAVASTATIN	4 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM CARBONATE (UNII: 45P3261C7T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	483
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1786-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206047	11/02/2023

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1784, 70771-1785, 70771-1786) , MANUFACTURE(70771-1784, 70771-1785, 70771-1786)