FLOLAN
- Product NDC
- 0173-0519
- 11-digit product format
- 001730519
- Labeler code
- 0173
- Product ID
- 0173-0519_38b7a328-0fa3-409f-b230-16bcbc8f4798
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epoprostenol sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- GlaxoSmithKline LLC
- Application
- NDA020444
- Marketing category
- NDA
- Marketing start
- 1995-12-08
- Marketing end
- 2026-05-31
- Substance
- EPOPROSTENOL SODIUM
- Active strength
- 1.5 mg/1
- Pharmacologic classes
- Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0173-0519-00 | FLOLAN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| EPOPROSTENOL SODIUM | ACTIVE INGREDIENT | 4K04IQ1OF4 | FLOLAN (EPOPROSTENOL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 10 | |
| EPOPROSTENOL | ACTIVE MOIETY | DCR9Z582X0 | FLOLAN (EPOPROSTENOL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 10 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | FLOLAN (EPOPROSTENOL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 10 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | FLOLAN (EPOPROSTENOL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 10 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | FLOLAN (EPOPROSTENOL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0173-0519 | FLOLAN (EPOPROSTENOL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION DILUENT (WATER) SOLUTION [GLAXOSMITHKLINE LLC] | 23 | Current NDC, Legacy NDC, 1 package rows | 20240915_8e4b636e-ee9c-4111-779d-28c8369d283b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0173-0519-00 | 00173051900 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0519-00) | 1995-12-08 | 2026-05-31 | No | No | Current |