Clopidogrel
- Product NDC
- 60505-3992
- 11-digit product format
- 605053992
- Labeler code
- 60505
- Product ID
- 60505-3992_2f390e08-7999-65b9-0efa-12c0768eec91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clopidogrel bisulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA076274
- Marketing category
- ANDA
- Marketing start
- 2012-05-17
- Marketing end
- 0000-00-00
- Substance
- CLOPIDOGREL BISULFATE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOPIDOGREL BISULFATE | 75 mg/1 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-3992-3 | Clopidogrel | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLOPIDOGREL BISULFATE | ACTIVE INGREDIENT | 08I79HTP27 | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| CLOPIDOGREL | ACTIVE MOIETY | A74586SNO7 | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| Hydroxypropyl Cellulose (Type H) | INACTIVE INGREDIENT | RFW2ET671P | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| METHYLCELLULOSE (15 CPS) | INACTIVE INGREDIENT | NPU9M2E6L8 | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
| ZINC STEARATE | INACTIVE INGREDIENT | H92E6QA4FV | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-3992 | CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] | 25 | Legacy NDC, 1 package rows | 20240925_edae8df1-caf9-ff72-1304-5ae8b355f8e7.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 |
|---|
| 60505-3992-3 | 60505399203 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-3992-3) | 2012-05-17 | 0000-00-00 | No | No | Current |