Clopidogrel
- Product NDC
- 52605-083
- 11-digit product format
- 526050083
- Labeler code
- 52605
- Product ID
- 52605-083_9e3256b5-2032-4615-967d-449d49b09921
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clopidogrel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- POLYGEN PHARMACEUTICALS INC.
- Application
- ANDA213351
- Marketing category
- ANDA
- Marketing start
- 2021-03-01
- 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
- 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 |
|---|
| 52605-083-05 | Clopidogrel | 500 in 1 BOTTLE, DISPENSING | TABLET | 500 | | 5 |
| 52605-083-13 | Clopidogrel | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52605-083 | CLOPIDOGREL TABLET CLOPIDOGREL TABLET [POLYGEN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220730_56b5d12b-b3fe-4de9-a5ef-80377c72d843.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 |
|---|
| 52605-083-05 | 52605008305 | 500 TABLET in 1 BOTTLE, DISPENSING (52605-083-05) | 500 tablet | 2021-03-01 | 0000-00-00 | No | No | Current |
| 52605-083-13 | 52605008313 | 30 TABLET in 1 BOTTLE (52605-083-13) | 30 tablet | 2021-03-01 | 0000-00-00 | No | No | Current |