Clopidogrel
- Product NDC
- 65162-414
- 11-digit product format
- 651620414
- Labeler code
- 65162
- Product ID
- 65162-414_360ed8dd-4f92-46fc-b31b-abe0d75e9bb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clopidogrel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA203751
- Marketing category
- ANDA
- Marketing start
- 2013-09-30
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clopidogrel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOPIDOGREL BISULFATE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 08I79HTP27 |
| Rxcui | 309362 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-414-03 | Clopidogrel | 30 in 1 BOTTLE | TABLET | 30 | | 24 |
| 65162-414-09 | Clopidogrel | 90 in 1 BOTTLE | TABLET | 90 | | 24 |
| 65162-414-11 | Clopidogrel | 1000 in 1 BOTTLE | TABLET | 1000 | | 24 |
| 65162-414-50 | Clopidogrel | 500 in 1 BOTTLE | TABLET | 500 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLOPIDOGREL BISULFATE | ACTIVE INGREDIENT | 08I79HTP27 | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| CLOPIDOGREL | ACTIVE MOIETY | A74586SNO7 | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-414 | CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS LLC] | 23 | Current NDC, Legacy NDC, 4 package rows | 20241027_0d010775-1160-4b2e-a928-563a02edd191.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-414-03 | 65162041403 | 30 TABLET in 1 BOTTLE (65162-414-03) | 30 tablet | 2013-09-30 | 0000-00-00 | No | No | Current |
| 65162-414-09 | 65162041409 | 90 TABLET in 1 BOTTLE (65162-414-09) | 90 tablet | 2013-09-30 | 0000-00-00 | No | No | Current |
| 65162-414-11 | 65162041411 | 1000 TABLET in 1 BOTTLE (65162-414-11) | 1000 tablet | 2013-09-30 | 0000-00-00 | No | No | Current |
| 65162-414-50 | 65162041450 | 500 TABLET in 1 BOTTLE (65162-414-50) | 500 tablet | 2013-09-30 | 0000-00-00 | No | No | Current |