ATORVASTATIN CALCIUM

Product NDC
50090-6440
11-digit product format
500906440
Labeler code
50090
Product ID
50090-6440_ca11c467-1901-4879-9e30-90c916fe56af
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
40 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
50090-6440-05009064400030 TABLET, FILM COATED in 1 BOTTLE (50090-6440-0) 2023-04-17NoNoHistorical
50090-6440-15009064400190 TABLET, FILM COATED in 1 BOTTLE (50090-6440-1) 2023-04-17NoNoHistorical
50090-6440-250090644002100 TABLET, FILM COATED in 1 BOTTLE (50090-6440-2) 2023-04-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ATORVASTATIN CALCIUMA-S Medication Solutions2023-07-21HUMAN PRESCRIPTION DRUG LABEL2