Clopidogrel bisulfate
- Product NDC
- 50228-121
- 11-digit product format
- 502280121
- Labeler code
- 50228
- Product ID
- 50228-121_0789c766-42ac-6467-e063-6294a90a2c6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clopidogrel bisulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals Inc
- Application
- ANDA204165
- Marketing category
- ANDA
- Marketing start
- 2015-09-15
- Substance
- CLOPIDOGREL BISULFATE
- Active strength
- 300 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 bisulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOPIDOGREL BISULFATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 08I79HTP27 |
| Rxcui | 309362, 749196 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-121-05 | Clopidogrel bisulfate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 20 |
| 50228-121-30 | Clopidogrel bisulfate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 20 |
| 50228-121-90 | Clopidogrel bisulfate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Clopidogrel bisulfate | ACTIVE INGREDIENT | 08I79HTP27 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| Clopidogrel | ACTIVE MOIETY | A74586SNO7 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-121 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 20 | Current NDC, Legacy NDC, 3 package rows | 20231013_d03cfc18-c9e4-41f8-b54d-6a7564c32afb.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 |
|---|
| 50228-121-05 | 50228012105 | 500 TABLET, FILM COATED in 1 BOTTLE (50228-121-05) | 2015-09-15 | 0000-00-00 | No | No | Current |
| 50228-121-30 | 50228012130 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-121-30) | 2015-09-15 | 0000-00-00 | No | No | Current |
| 50228-121-90 | 50228012190 | 90 TABLET, FILM COATED in 1 BOTTLE (50228-121-90) | 2015-09-15 | 0000-00-00 | No | No | Current |