Veletri
- Product NDC
- 66215-402
- 11-digit product format
- 662150402
- Labeler code
- 66215
- Product ID
- 66215-402_39e8b7f8-f82a-4083-a284-ce571a87ce97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epoprostenol
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Actelion Pharmaceuticals US, Inc.
- Application
- NDA022260
- Marketing category
- NDA
- Marketing start
- 2010-04-22
- Substance
- EPOPROSTENOL
- Active strength
- 1.5 mg/10mL
- Pharmacologic classes
- Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Veletri
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPOPROSTENOL | 1.5 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DCR9Z582X0 |
| Rxcui | 562501, 562502, 1009216, 1302755 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66215-402-01 | Veletri | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 15 |
| 66215-402-01 | Veletri | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| epoprostenol | ACTIVE INGREDIENT | DCR9Z582X0 | VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] | 3 | |
| epoprostenol | ACTIVE MOIETY | DCR9Z582X0 | VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] | 3 | |
| arginine | INACTIVE INGREDIENT | 94ZLA3W45F | VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] | 3 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] | 3 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66215-402 | VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20221130_df502787-46ec-4dd1-a2c0-be90f6d95a5d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66215-402-01 | 66215040201 | 1 VIAL in 1 CARTON (66215-402-01) / 10 mL in 1 VIAL | 1 vial | 2010-04-22 | 0000-00-00 | No | No | Current |