Atorvastatin Calcium
- Product NDC
- 0480-3588
- 11-digit product format
- 004803588
- Labeler code
- 0480
- Product ID
- 0480-3588_6c4083f7-0712-4028-8c8a-5cc7b086ecdf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA220276
- Marketing category
- ANDA
- Marketing start
- 2026-05-08
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 80 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 | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 259255 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-3588-10 | Atorvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
| 0480-3588-98 | Atorvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-3588-10 | 00480358810 | 1000 TABLET, FILM COATED in 1 BOTTLE (0480-3588-10) | 2026-05-08 | No | No | Historical |
| 0480-3588-98 | 00480358898 | 90 TABLET, FILM COATED in 1 BOTTLE (0480-3588-98) | 2026-05-20 | No | No | Historical |