ATORVASTATIN CALCIUM

Product NDC: 63629-8471
11-digit product format: 636298471
Labeler code: 63629
Product ID: 63629-8471_4ff3852d-482e-4ce1-a3a2-a2f019f40fc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA205519
Marketing category: ANDA
Marketing start: 2016-05-19
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 20 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 63629-8471_4ff3852d-482e-4ce1-a3a2-a2f019f40fc8
SPL ID: 4ff3852d-482e-4ce1-a3a2-a2f019f40fc8
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: ATORVASTATIN CALCIUM
Generic name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2016-05-19
Marketing category: ANDA
Application number: ANDA205519
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC]; Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
ATORVASTATIN CALCIUM TRIHYDRATE	20 mg/1

Package NDC	Description	Marketing start	Sample
63629-8471-1	90 TABLET, FILM COATED in 1 BOTTLE (63629-8471-1)	2016-05-19	No

UNII	Preferred term	Registry number	Matched term
48A5M73Z4Q	ATORVASTATIN CALCIUM TRIHYDRATE	344423-98-9	ATORVASTATIN CALCIUM TRIHYDRATE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
63629-8471-1	63629847101	90 TABLET, FILM COATED in 1 BOTTLE (63629-8471-1)	2016-05-19	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2025-11-11	HUMAN PRESCRIPTION DRUG LABEL	104
ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL	103