ATORVASTATIN CALCIUM

Product NDC
50090-7575
11-digit product format
500907575
Labeler code
50090
Product ID
50090-7575_bb421bfa-9f89-41eb-a0b8-f235bec19554
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA214344
Marketing category
ANDA
Marketing start
2024-10-01
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 formatDescriptionMarketing startSampleExclude flagStatus
50090-7575-05009075750090 TABLET, FILM COATED in 1 BOTTLE (50090-7575-0) 2025-06-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ATORVASTATIN CALCIUMA-S Medication Solutions2025-06-10HUMAN PRESCRIPTION DRUG LABEL1