Atorvastatin calcium
- Product NDC
- 68071-3948
- 11-digit product format
- 680713948
- Labeler code
- 68071
- Product ID
- 68071-3948_4847b77f-bbf1-4af5-e063-6394a90a5460
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA217081
- Marketing category
- ANDA
- Marketing start
- 2024-01-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atorvastatin calcium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 617311 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3948-3 | Atorvastatin calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3948-3 | 68071394803 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3948-3) | 2026-01-13 | No | No | Historical |