ATORVASTATIN CALCIUM

Product NDC
51655-946
11-digit product format
516550946
Labeler code
51655
Product ID
51655-946_4bc15e11-0610-7b32-e063-6394a90ada06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA207687
Marketing category
ANDA
Marketing start
2022-03-23
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
2027-12-31
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
51655-946-525165509465230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-946-52) 2022-03-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ATORVASTATIN CALCIUMNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL5