ATORVASTATIN CALCIUM
- Product NDC
- 0904-6293
- 11-digit product format
- 009046293
- Labeler code
- 0904
- Product ID
- 0904-6293_cfa7738f-f1a2-41ef-975e-ffa8f94f1b44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA090548
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- Substance
- ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
- 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 CALCIUM PROPYLENE GLYCOL SOLVATE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YRZ789OWMI |
| Rxcui | 259255, 617311 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6293-04 | ATORVASTATIN CALCIUM | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 10 |
| 0904-6293-04 | ATORVASTATIN CALCIUM | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE | ACTIVE INGREDIENT | YRZ789OWMI | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| ATORVASTATIN | ACTIVE MOIETY | A0JWA85V8F | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| CALCIUM ACETATE | INACTIVE INGREDIENT | Y882YXF34X | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6293 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240621_e74278b6-31fc-48d4-97b7-ba500e9e15fb.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 |
|---|
| 0904-6293-04 | 00904629304 | 30 BLISTER PACK in 1 CARTON (0904-6293-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2014-10-31 | 0000-00-00 | No | No | Current |