Atorvastatin Calcium
- Product NDC
- 51079-210
- 11-digit product format
- 510790210
- Labeler code
- 51079
- Product ID
- 51079-210_3a398bf9-4f72-46b9-e063-6394a90af2d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA091226
- Marketing category
- ANDA
- Marketing start
- 2014-01-29
- 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
- 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 TRIHYDRATE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| 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 |
|---|
| 51079-210-01 | Atorvastatin Calcium | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 15 |
| 51079-210-20 | Atorvastatin Calcium | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | ACTIVE INGREDIENT | 48A5M73Z4Q | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| ATORVASTATIN | ACTIVE MOIETY | A0JWA85V8F | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| ARGININE | INACTIVE INGREDIENT | 94ZLA3W45F | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-210 | ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250331_7c1083b9-7a20-475d-ba12-4f5d0b53e601.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 |
|---|
| 51079-210-01 | 51079021001 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-210-20 | 51079021020 | 100 BLISTER PACK in 1 CARTON (51079-210-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-210-01) | 100 blister pack | 2014-01-29 | 0000-00-00 | No | No | Current |