ATORVASTATIN CALCIUM
- Product NDC
- 53002-2440
- 11-digit product format
- 530022440
- Labeler code
- 53002
- Product ID
- 53002-2440_f9ca681f-8833-42d6-aebb-e844a2d0c16b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA207687
- Marketing category
- ANDA
- Marketing start
- 2018-08-06
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-2440-0 | 2025-01-30 | C162847 | 48780-1 | f386c64a-2662-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-2440-3 | 2025-01-30 | C162847 | 48780-1 | f386c64a-2662-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-2440-9 | 2025-01-30 | C162847 | 48780-1 | f386c64a-2662-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-2440-0 | 2023-06-08 | C162847 | 48780-1 | f386c64a-2662-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-2440-3 | 2023-06-08 | C162847 | 48780-1 | f386c64a-2662-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-2440-9 | 2023-06-08 | C162847 | 48780-1 | f386c64a-2662-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-2440-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2662-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-2440-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2662-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-2440-9 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2662-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2440-0 | ATORVASTATIN CALCIUM | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 53002-2440-3 | ATORVASTATIN CALCIUM | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 53002-2440-9 | ATORVASTATIN CALCIUM | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2440 | ATORVASTATIN CALCIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20230609_6f63426a-6a79-4a8a-97b7-8fc86b340041.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 |
|---|
| 53002-2440-0 | 53002244000 | 100 TABLET, FILM COATED in 1 BOTTLE (53002-2440-0) | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-2440-3 | 53002244003 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-2440-3) | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-2440-9 | 53002244009 | 90 TABLET, FILM COATED in 1 BOTTLE (53002-2440-9) | 2020-01-01 | 0000-00-00 | No | No | Current |