ATORVASTATIN CALCIUM
- Product NDC
- 68071-3701
- 11-digit product format
- 680713701
- Labeler code
- 68071
- Product ID
- 68071-3701_251828bd-c8cd-87d2-e063-6394a90a317f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA214344
- Marketing category
- ANDA
- Marketing start
- 2023-09-12
- 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 |
|---|
| 68071-3701-9 | 68071370109 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3701-9) | 2024-10-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ATORVASTATIN CALCIUM | NuCare Pharmaceuticals, Inc. | 2024-10-22 | HUMAN PRESCRIPTION DRUG LABEL | 1 |