Atorvastatin Calcium

Product NDC
67046-1458
11-digit product format
670461458
Labeler code
67046
Product ID
67046-1458_2d914698-dfd0-014f-e063-6294a90aea25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA214659
Marketing category
ANDA
Marketing start
2025-02-07
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1458-36704614580330 TABLET in 1 BLISTER PACK (67046-1458-3) 30 tablet2025-02-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atorvastatin CalciumCoupler LLC2025-02-07HUMAN PRESCRIPTION DRUG LABEL1