Clopidogrel bisulfate
- Product NDC
- 70400-101
- 11-digit product format
- 704000101
- Labeler code
- 70400
- Product ID
- 70400-101_67659157-d20c-1bb5-e053-2991aa0ab615
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clopidogrel bisulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sterisyn Inc.
- Application
- ANDA204165
- Marketing category
- ANDA
- Marketing start
- 2018-03-01
- 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
- 2019-12-31
- 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 |
|---|
| 70400-101-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-24a9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997 |
| 70400-101-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-24a9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997 |
| 70400-101-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-24a9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP 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 |
|---|
| 70400-101-10 | Clopidogrel bisulfate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 70400-101-30 | Clopidogrel bisulfate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 70400-101-90 | Clopidogrel bisulfate | 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 |
|---|
| 70400-101 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STERISYN INC.] | 3 | Legacy NDC, 3 package rows | 20180328_664895aa-9009-1423-e053-2a91aa0ad326.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 70400-101-10 | 70400010110 | 1000 in 1 BOTTLE | Historical |
| 70400-101-30 | 70400010130 | 30 in 1 BOTTLE | Historical |
| 70400-101-90 | 70400010190 | 90 in 1 BOTTLE | Historical |