NDC 68071-3470-6
API & Excipient Details

Atorvastatin marketed by NuCare Pharmaceuticals,Inc. under NDC Code 68071-3470-6

NDC Code(s) : 68071-3470-6
Packager : NuCare Pharmaceuticals,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

atorvastatin calciumatorvastatin film coated TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:68071-3470(NDC:70377-028)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	20 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE(UNII: H0G9379FGK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	white (White to Off White Oval Shaped Tablet)	Score	no score
Shape	OVAL	Size	11 mm
Flavor		Imprint Code	114
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68071-3470-6	60 in 1 BOTTLE Type 0: Not a Combination Product	26/07/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209912	06/18/2018

LABELER - NuCare Pharmaceuticals,Inc.(010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	repack(68071-3470)

PRINCIPAL DISPLAY PANEL