ATORVASTATIN CALCIUM
- Product NDC
- 43063-453
- 11-digit product format
- 430630453
- Labeler code
- 43063
- Product ID
- 43063-453_36b1104c-098f-7f21-e063-6394a90a0f0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA090548
- Marketing category
- ANDA
- Marketing start
- 2012-05-29
- 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
- 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YRZ789OWMI |
| Rxcui | 617311 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-453-30 | ATORVASTATIN CALCIUM | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 35 |
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 [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| ATORVASTATIN | ACTIVE MOIETY | A0JWA85V8F | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| CALCIUM ACETATE | INACTIVE INGREDIENT | Y882YXF34X | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-453 | ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 34 | Current NDC, Legacy NDC, 1 package rows | 20250302_5412835b-27c6-461f-97b9-b5bf03afe7f2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-453-30 | 43063045330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-453-30) | 2012-05-29 | 0000-00-00 | No | No | Current |