Atorvastatin calcium

Product NDC
71205-765
11-digit product format
712050765
Labeler code
71205
Product ID
71205-765_514fcba1-713c-4aeb-be8c-369fcf9b4ffe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211933
Marketing category
ANDA
Marketing start
2019-02-08
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
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 formatDescriptionMarketing startSampleExclude flagStatus
71205-765-307120507653030 TABLET, FILM COATED in 1 BOTTLE (71205-765-30) 2023-02-15NoNoHistorical
71205-765-607120507656060 TABLET, FILM COATED in 1 BOTTLE (71205-765-60) 2023-02-15NoNoHistorical
71205-765-907120507659090 TABLET, FILM COATED in 1 BOTTLE (71205-765-90) 2023-02-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atorvastatin calciumProficient Rx LP2023-02-01HUMAN PRESCRIPTION DRUG LABEL1