NDC 0173-0519

FLOLAN

Epoprostenol Sodium

FLOLAN is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Epoprostenol Sodium.

• Product ID: 0173-0519_0cf298ad-7945-4bd1-9ee9-b988f4452a6e
• NDC: 0173-0519
• Product Type: Human Prescription Drug
• Proprietary Name: FLOLAN
• Generic Name: Epoprostenol Sodium
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1995-12-08
• Marketing Category: NDA / NDA
• Application Number: NDA020444
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: EPOPROSTENOL SODIUM
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Prostacycline Vasodilator [EPC],Prostaglandins I [CS],Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0173-0519-00

1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0519-00)

• Marketing Start Date: 1995-12-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0519-00 [00173051900]

FLOLAN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020444
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1995-12-08

Drug Details

Active Ingredients

Ingredient	Strength
EPOPROSTENOL SODIUM	1.5 mg/1

OpenFDA Data

• SPL SET ID: 8e4b636e-ee9c-4111-779d-28c8369d283b
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 4K04IQ1OF4
  • 059QF0KO0R
• RxNorm Concept Unique ID - RxCUI:
  • 211200
  • 562501
  • 562502
  • 211199

Pharmacological Class

• Prostacycline Vasodilator [EPC]
• Prostaglandins I [CS]
• Vasodilation [PE]

NDC Crossover Matching brand name "FLOLAN" or generic name "Epoprostenol Sodium"

NDC	Brand Name	Generic Name
0173-0517	FLOLAN	epoprostenol sodium
0173-0519	FLOLAN	epoprostenol sodium
0703-1985	Epoprostenol Sodium	Epoprostenol Sodium
0703-1995	Epoprostenol Sodium	Epoprostenol Sodium