Atorvastatin Calcium

Product NDC
68071-3580
11-digit product format
680713580
Labeler code
68071
Product ID
68071-3580_12750e3b-b423-09d6-e063-6394a90a5b3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA216436
Marketing category
ANDA
Marketing start
2023-03-01
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
68071-3580-96807135800990 TABLET, FILM COATED in 1 BOTTLE (68071-3580-9) 2024-02-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atorvastatin CalciumNuCare Pharmaceuticals,Inc.2024-02-28HUMAN PRESCRIPTION DRUG LABEL1