ATORVASTATIN CALCIUM

Product NDC
63629-8470
11-digit product format
636298470
Labeler code
63629
Product ID
63629-8470_b65734de-9d94-4930-9657-b7c7a3c6a2a5
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-8470-163629847001500 TABLET, FILM COATED in 1 BOTTLE (63629-8470-1) 2016-05-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ATORVASTATIN CALCIUMBryant Ranch Prepack2025-11-11HUMAN PRESCRIPTION DRUG LABEL104
ATORVASTATIN CALCIUMBryant Ranch Prepack2024-09-05HUMAN PRESCRIPTION DRUG LABEL103