Clopidogrel
- Product NDC
- 53002-1672
- 11-digit product format
- 530021672
- Labeler code
- 53002
- Product ID
- 53002-1672_09fa4a76-071b-4364-964a-c6e9be0f812d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clopidogrel Bisulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA090540
- Marketing category
- ANDA
- Marketing start
- 2012-05-17
- Marketing end
- 0000-00-00
- Substance
- CLOPIDOGREL BISULFATE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 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 |
|---|
| 53002-1672-0 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
| 53002-1672-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
| 53002-1672-0 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
| 53002-1672-3 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
| 53002-1672-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
| 53002-1672-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
| 53002-1672-0 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
| 53002-1672-3 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
| 53002-1672-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
| 53002-1672-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bc92-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1672-0 | Clopidogrel | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 53002-1672-3 | Clopidogrel | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1672 | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20230609_5da7468b-b829-4624-b84d-84bdebf61a0d.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 |
|---|
| 53002-1672-0 | 53002167200 | 100 TABLET, FILM COATED in 1 BOTTLE (53002-1672-0) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-1672-3 | 53002167203 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-1672-3) | 2018-10-01 | 0000-00-00 | No | No | Current |