epoprostenol
- Product NDC
- 62756-060
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epoprostenol
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA210473
- Marketing category
- ANDA
- Substance
- EPOPROSTENOL SODIUM
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 62756-060-40 | 1 VIAL in 1 CARTON (62756-060-40) / 10 mL in 1 VIAL | 2021-01-16 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| These highlights do not include all the information needed to use EPOPROSTENOL FOR INJECTION safely and effectively. See full prescribing information for EPOPROSTENOL FOR INJECTION. EPOPROSTENOL for injection, for intravenous use Initial U.S. Approval: 1995 | Sun Pharmaceutical Industries, Inc. | 2025-04-23 | Human Prescription Drug Label | 6 |