NDC 60635-133

Varithena

Polidocanol

Varithena is a Kit in the Human Prescription Drug category. It is labeled and distributed by Biocompatibles, Inc.. The primary component is .

• Product ID: 60635-133_2c9274b3-4b99-4d9c-b90a-7f30379eb597
• NDC: 60635-133
• Product Type: Human Prescription Drug
• Proprietary Name: Varithena
• Generic Name: Polidocanol
• Dosage Form: Kit
• Marketing Start Date: 2013-11-25
• Marketing Category: NDA / NDA
• Application Number: NDA205098
• Labeler Name: Biocompatibles, Inc.
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 60635-133-01

1 CARTON in 1 PACKAGE (60635-133-01) > 1 POUCH in 1 CARTON > 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER

• Marketing Start Date: 2016-06-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60635-133-01 [60635013301]

Varithena KIT

• Marketing Category: NDA
• Application Number: NDA205098
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-06-22
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-03-12

Drug Details

OpenFDA Data

• SPL SET ID: dfd6b4a0-b0dc-11e2-9e96-0800200c9a66
• Manufacturer:
  • Biocompatibles, Inc.
• RxNorm Concept Unique ID - RxCUI:
  • 1485070
  • 1485068

NDC Crossover Matching brand name "Varithena" or generic name "Polidocanol"

NDC	Brand Name	Generic Name
60635-107	Varithena	polidocanol
60635-111	Varithena	polidocanol
60635-118	Varithena	polidocanol
60635-123	Varithena	polidocanol
60635-133	Varithena	polidocanol
46783-121	Asclera	POLIDOCANOL
46783-221	Asclera	POLIDOCANOL
67850-140	Asclera	POLIDOCANOL
67850-141	Asclera	POLIDOCANOL