clopidogrel
- Product NDC
- 31722-901
- 11-digit product format
- 317220901
- Labeler code
- 31722
- Product ID
- 31722-901_5ac8bdbe-355f-4271-a45b-cf38522e787d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clopidogrel
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204165
- Marketing category
- ANDA
- Marketing start
- 2016-03-03
- 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 |
|---|
| 31722-901-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3415-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 |
| 31722-901-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3415-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 |
| 31722-901-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3415-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 |
| 31722-901-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3415-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 |
| 31722-901-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3415-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 |
|---|
| 31722-901-01 | clopidogrel | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 31722-901-05 | clopidogrel | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 31722-901-10 | clopidogrel | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
| 31722-901-30 | clopidogrel | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 31722-901-90 | clopidogrel | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLOPIDOGREL BISULFATE | ACTIVE INGREDIENT | 08I79HTP27 | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CLOPIDOGREL | ACTIVE MOIETY | A74586SNO7 | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLOPIDROGREL (CLOPIDOGREL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-901 | CLOPIDOGREL TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 5 package rows | 20170911_be5aae47-c2d3-4576-8588-a4b09fce91b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 31722-901-01 | 31722090101 | 100 in 1 BOTTLE | Historical |
| 31722-901-05 | 31722090105 | 500 in 1 BOTTLE | Historical |
| 31722-901-10 | 31722090110 | 1000 in 1 BOTTLE | Historical |
| 31722-901-30 | 31722090130 | 30 in 1 BOTTLE | Historical |
| 31722-901-90 | 31722090190 | 90 in 1 BOTTLE | Historical |