Eptifibatide
- Product NDC
- 67457-629
- 11-digit product format
- 674570629
- Labeler code
- 67457
- Product ID
- 67457-629_e966c894-560e-4805-bdd5-16e153bb4687
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eptifibatide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA203258
- Marketing category
- ANDA
- Marketing start
- 2018-10-01
- Substance
- EPTIFIBATIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eptifibatide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPTIFIBATIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NA8320J834 |
| Rxcui | 200349, 1736470, 1736477 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-629-10 | Eptifibatide | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 67457-629-10 | Eptifibatide | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-629 | EPTIFIBATIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20210724_88a37f9c-496b-4a6b-9665-4550abba04f1.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 |
|---|
| 67457-629-10 | 67457062910 | 1 VIAL in 1 CARTON (67457-629-10) / 10 mL in 1 VIAL | 1 vial | 2018-10-01 | 0000-00-00 | No | No | Current |