Eptifibatide
- Product NDC
- 71288-412
- 11-digit product format
- 712880412
- Labeler code
- 71288
- Product ID
- 71288-412_a15dafa6-7923-4999-8938-28e580304e57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eptifibatide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA213599
- Marketing category
- ANDA
- Marketing start
- 2024-05-09
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-412-10 | Eptifibatide | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
| 71288-412-10 | Eptifibatide | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-412 | EPTIFIBATIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 8 | Current NDC, 2 package rows | 20240516_3e7e7cd3-8efa-4d91-a5ab-7fd78b0cc65e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-412-10 | 71288041210 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-412-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2024-05-09 | No | No | Current |