Atorvastatin Calcium

Product NDC
68788-8887
11-digit product format
687888887
Labeler code
68788
Product ID
68788-8887_7fc58ce3-f069-409b-b36f-bb23ce21fb6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209912
Marketing category
ANDA
Marketing start
2025-09-23
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8887-168788888701100 TABLET in 1 BOTTLE (68788-8887-1) 100 tablet2025-09-23NoNoHistorical
68788-8887-36878888870330 TABLET in 1 BOTTLE (68788-8887-3) 30 tablet2025-09-23NoNoHistorical
68788-8887-66878888870660 TABLET in 1 BOTTLE (68788-8887-6) 60 tablet2025-09-23NoNoHistorical
68788-8887-96878888870990 TABLET in 1 BOTTLE (68788-8887-9) 90 tablet2025-09-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atorvastatin CalciumPreferred Pharmaceuticals Inc.2025-09-23HUMAN PRESCRIPTION DRUG LABEL1