Eptifibatide
- Product NDC
- 83634-300
- 11-digit product format
- 836340300
- Labeler code
- 83634
- Product ID
- 83634-300_74e580c1-7f30-49cf-8e83-968bc05c5559
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eptifibatide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avenacy Inc.
- Application
- ANDA213081
- Marketing category
- ANDA
- Marketing start
- 2024-01-31
- 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 |
|---|
| 83634-300-10 | Eptifibatide | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 2 |
| 83634-300-10 | Eptifibatide | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-300 | EPTIFIBATIDE INJECTION, SOLUTION [AVENACY INC.] | 2 | Current NDC, 2 package rows | 20240820_c0781dae-3ef6-4cab-b084-01d2e45f3764.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83634-300-10 | 83634030010 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-300-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2024-01-31 | No | No | Current |