Eptifibatide
- Product NDC
- 52958-402
- 11-digit product format
- 529580402
- Labeler code
- 52958
- Product ID
- 52958-402_6f3dec26-ea9b-4e6e-8e5b-0fa6fb430598
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eptifibatide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hainan Shuangcheng Pharmaceuticals Co., Ltd.
- Application
- ANDA213081
- Marketing category
- ANDA
- Marketing start
- 2021-09-07
- 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 |
|---|
| 52958-402-01 | Eptifibatide | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
| 52958-402-01 | Eptifibatide | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52958-402 | EPTIFIBATIDE INJECTION, SOLUTION [HAINAN SHUANGCHENG PHARMACEUTICALS CO., LTD.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241220_c488f1af-a82c-4360-8886-79520635561a.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 |
|---|
| 52958-402-01 | 52958040201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (52958-402-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2021-09-07 | 0000-00-00 | No | No | Current |