Atorvastatin Calcium

Product NDC
68071-3868
11-digit product format
680713868
Labeler code
68071
Product ID
68071-3868_37780cb8-06f8-2263-e063-6394a90abba8
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
2023-10-20
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3868-36807138680330 TABLET in 1 BOTTLE (68071-3868-3) 30 tablet2025-06-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atorvastatin CalciumNuCare Pharmaceuticals,Inc.2025-06-13HUMAN PRESCRIPTION DRUG LABEL1