atorvastatin calcium

Product NDC
68071-2994
11-digit product format
680712994
Labeler code
68071
Product ID
68071-2994_2d53e488-a010-123b-e063-6294a90aa8ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209912
Marketing category
ANDA
Marketing start
2018-06-18
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
68071-2994-96807129940990 TABLET in 1 BOTTLE (68071-2994-9) 90 tablet2023-05-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
atorvastatin calciumNuCare Pharmaceuticals,Inc.2025-02-04HUMAN PRESCRIPTION DRUG LABEL2