Eptifibatide
- Product NDC
- 0338-9558
- 11-digit product format
- 003389558
- Labeler code
- 0338
- Product ID
- 0338-9558_a90f397a-95b8-421c-9e34-b327671f97a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eptifibatide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Company
- Application
- ANDA208554
- Marketing category
- ANDA
- Marketing start
- 2019-02-01
- Substance
- EPTIFIBATIDE
- Active strength
- 75 mg/100mL
- Pharmacologic classes
- Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eptifibatide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPTIFIBATIDE | 75 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NA8320J834 |
| Rxcui | 200349 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0338-9558-10 | Eptifibatide | 100 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 100 | | 13 |
| 0338-9558-10 | Eptifibatide | 1 in 1 CARTON | INJECTION | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0338-9558 | EPTIFIBATIDE INJECTION [BAXTER HEALTHCARE CORPORATION] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240601_5f46b76b-5c83-49b9-ada8-4ad5cf81a38c.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 |
|---|
| 0338-9558-10 | 00338955810 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10) / 100 mL in 1 VIAL, SINGLE-DOSE | 2019-02-01 | 0000-00-00 | No | No | Current |