atorvastatin calcium

Product NDC
50090-7725
11-digit product format
500907725
Labeler code
50090
Product ID
50090-7725_c0edb2fe-25f7-414d-9552-eb6da407d901
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206536
Marketing category
ANDA
Marketing start
2024-06-12
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 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
50090-7725-05009077250090 TABLET in 1 BOTTLE (50090-7725-0) 90 tablet2025-10-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
atorvastatin calciumA-S Medication Solutions2025-10-21HUMAN PRESCRIPTION DRUG LABEL1