Epoprostenol
- Product NDC
- 68083-707
- 11-digit product format
- 680830707
- Labeler code
- 68083
- Product ID
- 68083-707_8b45ebae-92d6-4a3b-a559-115c66a8352a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epoprostenol
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA219237
- Marketing category
- ANDA
- Marketing start
- 2025-12-29
- Substance
- EPOPROSTENOL
- Active strength
- .5 mg/10mL
- Pharmacologic classes
- Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Epoprostenol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPOPROSTENOL | .5 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DCR9Z582X0 |
| Rxcui | 562501, 562502 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-707-01 | Epoprostenol | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 68083-707-01 | Epoprostenol | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-707-01 | 68083070701 | 1 VIAL in 1 CARTON (68083-707-01) / 10 mL in 1 VIAL | 1 vial | 2025-12-29 | No | No | Current |