Atorvastatin Calcium
- Product NDC
- 68084-590
- 11-digit product format
- 680840590
- Labeler code
- 68084
- Product ID
- 68084-590_39f9b643-99a3-1a0d-e063-6294a90a5afe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA090548
- Marketing category
- ANDA
- Marketing start
- 2013-03-18
- 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, 617310, 617311, 617312 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-590-25 | Atorvastatin Calcium | 30 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 30 | | 12 |
| 68084-590-95 | Atorvastatin Calcium | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 12 |
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 [AMERICAN HEALTH PACKAGING] | 3 | |
| ATORVASTATIN | ACTIVE MOIETY | A0JWA85V8F | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| CALCIUM ACETATE | INACTIVE INGREDIENT | Y882YXF34X | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-590 | ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240904_6d203e05-1fe6-4262-9d66-b461f84c4672.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 |
|---|
| 68084-590-25 | 68084059025 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-590-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-590-95) | 30 blister pack | 2013-03-18 | 0000-00-00 | No | No | Current |
| 68084-590-95 | 68084059095 | 1 in 1 BLISTER PACK | | | | | | Historical |