NDC 63629-3366-4
API & Excipient Details

Atorvastatin marketed by Bryant Ranch Prepack under NDC Code 63629-3366-4

NDC Code(s) : 63629-3366-1, 63629-3366-2, 63629-3366-3, 63629-3366-4, 63629-3366-5
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LipitorATORVASTATIN CALCIUM TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63629-3366(NDC:0071-0158)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATORVASTATIN CALCIUM(UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	80 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE(UNII: H0G9379FGK)
CANDELILLA WAX(UNII: WL0328HX19)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL (elliptical)	Size	19 mm
Flavor		Imprint Code	PD;158;80
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63629-3366-1	30 in 1 BOTTLE
2	NDC:63629-3366-2	60 in 1 BOTTLE
3	NDC:63629-3366-3	100 in 1 BOTTLE
4	NDC:63629-3366-4	180 in 1 BOTTLE
5	NDC:63629-3366-5	90 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020702	04/07/2000

PRINCIPAL DISPLAY PANEL