Atorvastatin calcium
- Product NDC
- 75834-258
- 11-digit product format
- 758340258
- Labeler code
- 75834
- Product ID
- 75834-258_4580fe3c-b524-3a14-e063-6294a90a34d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NIVAGEN PHARMACEUTICALS, INC.
- Application
- ANDA213853
- Marketing category
- ANDA
- Marketing start
- 2020-08-26
- Substance
- ATORVASTATIN
- Active strength
- 80 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atorvastatin calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATORVASTATIN | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A0JWA85V8F |
| Rxcui | 259255, 617310, 617311, 617312 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-258-01 | Atorvastatin calcium | 1000 in 1 BOTTLE | TABLET | 1000 | | 17 |
| 75834-258-02 | Atorvastatin calcium | 2000 in 1 BOTTLE | TABLET | 2000 | | 17 |
| 75834-258-50 | Atorvastatin calcium | 500 in 1 BOTTLE | TABLET | 500 | | 17 |
| 75834-258-90 | Atorvastatin calcium | 90 in 1 BOTTLE | TABLET | 90 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-258 | ATORVASTATIN CALCIUM TABLET [NIVAGEN PHARMACEUTICALS, INC.] | 16 | Current NDC, Legacy NDC, 4 package rows | 20250313_7c58bf4a-4a92-4db8-89bc-4de1b5831efc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-258-01 | 75834025801 | 1000 TABLET in 1 BOTTLE (75834-258-01) | 1000 tablet | 2020-08-26 | 0000-00-00 | No | No | Current |
| 75834-258-02 | 75834025802 | 2000 TABLET in 1 BOTTLE (75834-258-02) | 2000 tablet | 2020-08-26 | 0000-00-00 | No | No | Current |
| 75834-258-50 | 75834025850 | 500 TABLET in 1 BOTTLE (75834-258-50) | 500 tablet | 2020-08-26 | 0000-00-00 | No | No | Current |
| 75834-258-90 | 75834025890 | 90 TABLET in 1 BOTTLE (75834-258-90) | 90 tablet | 2020-08-26 | 0000-00-00 | No | No | Current |