Atorvastatin Calcium

Product NDC
82804-026
11-digit product format
828040026
Labeler code
82804
Product ID
82804-026_ba7a8604-93bb-4b82-b160-328ed17f89f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209288
Marketing category
ANDA
Marketing start
2018-12-23
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
82804-026-308280400263030 TABLET, FILM COATED in 1 BOTTLE (82804-026-30) 2023-10-13NoNoHistorical
82804-026-608280400266060 TABLET, FILM COATED in 1 BOTTLE (82804-026-60) 2023-10-13NoNoHistorical
82804-026-908280400269090 TABLET, FILM COATED in 1 BOTTLE (82804-026-90) 2023-10-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atorvastatin CalciumProficient Rx LP2023-10-01HUMAN PRESCRIPTION DRUG LABEL1