ATORVASTATIN CALCIUM
- Product NDC
- 58517-001
- 11-digit product format
- 585170001
- Labeler code
- 58517
- Product ID
- 58517-001_e8f80f38-13c2-4688-85d9-f99510e08d92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- New Horizon Rx Group, LLC
- Application
- ANDA090548
- Marketing category
- ANDA
- Marketing start
- 2013-08-25
- Marketing end
- 0000-00-00
- Substance
- ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58517-001-30 | ATORVASTATIN CALCIUM | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
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 [NEW HORIZON RX GROUP, LLC] | 3 | |
| ATORVASTATIN | ACTIVE MOIETY | A0JWA85V8F | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| CALCIUM ACETATE | INACTIVE INGREDIENT | Y882YXF34X | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58517-001 | ATORVASTATIN CALCIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 3 | Legacy NDC, 1 package rows | 20140103_01a908f1-fe8b-4bf1-bf0d-ce17040d0c4c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 58517-001-30 | 58517000130 | 30 in 1 BOTTLE | Historical |