ATORVASTATIN CALCIUM
- Product NDC
- 67046-1442
- 11-digit product format
- 670461442
- Labeler code
- 67046
- Product ID
- 67046-1442_2de6c979-6b84-5bea-e063-6394a90a3713
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA214344
- Marketing category
- ANDA
- Marketing start
- 2025-02-11
- 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 UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 48A5M73Z4Q | ATORVASTATIN CALCIUM TRIHYDRATE | 344423-98-9 | ATORVASTATIN CALCIUM TRIHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1442-3 | 67046144203 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1442-3) | 2025-02-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ATORVASTATIN CALCIUM | Coupler LLC | 2025-02-11 | HUMAN PRESCRIPTION DRUG LABEL | 1 |