FLOLAN
These highlights do not include all the information needed to use FLOLAN safely and effectively. See full prescribing information for FLOLAN. FLOLAN (epoprostenol sodium) for injection, for intravenous useInitial U.S. Approval: 1995
Approved
Approval ID
8e4b636e-ee9c-4111-779d-28c8369d283b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2023
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
water
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0857
Application NumberNDA020444
Product Classification
M
Marketing Category
C73594
G
Generic Name
water
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 24, 2021
FDA Product Classification
INGREDIENTS (4)
WATERActive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: ACTIB
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
epoprostenol sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0519
Application NumberNDA020444
Product Classification
M
Marketing Category
C73594
G
Generic Name
epoprostenol sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 24, 2021
FDA Product Classification
INGREDIENTS (4)
EPOPROSTENOL SODIUMActive
Quantity: 1.5 mg in 1 1
Code: 4K04IQ1OF4
Classification: ACTIM
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
epoprostenol sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0517
Application NumberNDA020444
Product Classification
M
Marketing Category
C73594
G
Generic Name
epoprostenol sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 24, 2021
FDA Product Classification
INGREDIENTS (4)
EPOPROSTENOL SODIUMActive
Quantity: 0.5 mg in 1 1
Code: 4K04IQ1OF4
Classification: ACTIM
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT