Atorvastatin calcium

Product NDC
71335-2977
11-digit product format
713352977
Labeler code
71335
Product ID
71335-2977_dc22d1df-cdbf-4bf5-a90a-7c0f2370e030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211933
Marketing category
ANDA
Marketing start
2019-02-08
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
48A5M73Z4QATORVASTATIN CALCIUM TRIHYDRATE344423-98-9ATORVASTATIN CALCIUM TRIHYDRATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2977-17133529770130 TABLET, FILM COATED in 1 BOTTLE (71335-2977-1) 2025-11-06NoNoHistorical
71335-2977-27133529770290 TABLET, FILM COATED in 1 BOTTLE (71335-2977-2) 2025-11-06NoNoHistorical
71335-2977-37133529770360 TABLET, FILM COATED in 1 BOTTLE (71335-2977-3) 2025-11-06NoNoHistorical
71335-2977-471335297704120 TABLET, FILM COATED in 1 BOTTLE (71335-2977-4) 2025-11-06NoNoHistorical
71335-2977-571335297705100 TABLET, FILM COATED in 1 BOTTLE (71335-2977-5) 2025-11-06NoNoHistorical
71335-2977-671335297706180 TABLET, FILM COATED in 1 BOTTLE (71335-2977-6) 2025-11-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atorvastatin calciumBryant Ranch Prepack2025-11-06HUMAN PRESCRIPTION DRUG LABEL1