Atorvastatin Calcium

Product NDC
68071-2991
11-digit product format
680712991
Labeler code
68071
Product ID
68071-2991_1858a056-ce29-a5fb-e063-6394a90a283f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA214659
Marketing category
ANDA
Marketing start
2022-08-29
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2991-36807129910330 TABLET in 1 BOTTLE (68071-2991-3) 30 tablet2023-04-25NoNoHistorical
68071-2991-96807129910990 TABLET in 1 BOTTLE (68071-2991-9) 90 tablet2023-04-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atorvastatin CalciumNuCare Pharmaceuticals,Inc.2024-05-13HUMAN PRESCRIPTION DRUG LABEL2