Atorvastatin Calcium

Product NDC
70518-4592
11-digit product format
705184592
Labeler code
70518
Product ID
70518-4592_4d754776-5d90-8e80-e063-6394a90a045e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214659
Marketing category
ANDA
Marketing start
2026-03-20
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4592-07051845920030 TABLET in 1 BLISTER PACK (70518-4592-0) 30 tablet2026-03-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atorvastatin CalciumREMEDYREPACK INC.2026-03-20HUMAN PRESCRIPTION DRUG LABEL1