ATORVASTATIN CALCIUM

Product NDC
50090-6479
11-digit product format
500906479
Labeler code
50090
Product ID
50090-6479_8b4f3dc2-8a87-4c0d-915a-e4fdf16c5691
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090548
Marketing category
ANDA
Marketing start
2021-08-01
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
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
YRZ789OWMIATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE1040350-07-9ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6479-05009064790030 TABLET, FILM COATED in 1 BOTTLE (50090-6479-0) 2023-05-17NoNoHistorical
50090-6479-15009064790190 TABLET, FILM COATED in 1 BOTTLE (50090-6479-1) 2023-05-17NoNoHistorical
50090-6479-250090647902100 TABLET, FILM COATED in 1 BOTTLE (50090-6479-2) 2023-05-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ATORVASTATIN CALCIUMA-S Medication Solutions2023-11-26HUMAN PRESCRIPTION DRUG LABEL1