Product NDC: | 0173-0517 |
Proprietary Name: | FLOLAN |
Non Proprietary Name: | epoprostenol sodium |
Active Ingredient(s): | .5 mg/1 & nbsp; epoprostenol sodium |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0173-0517 |
Labeler Name: | GlaxoSmithKline LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020444 |
Marketing Category: | NDA |
Start Marketing Date: | 19951208 |
Package NDC: | 0173-0517-00 |
Package Description: | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0517-00) |
NDC Code | 0173-0517-00 |
Proprietary Name | FLOLAN |
Package Description | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0517-00) |
Product NDC | 0173-0517 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | epoprostenol sodium |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 19951208 |
Marketing Category Name | NDA |
Labeler Name | GlaxoSmithKline LLC |
Substance Name | EPOPROSTENOL SODIUM |
Strength Number | .5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] |