NDC 60635-123

Varithena TM

Polidocanol

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

• Product ID: 60635-123_636003c5-8a21-4380-909c-36f00c05fd88
• NDC: 60635-123
• Product Type: Human Prescription Drug
• Proprietary Name: Varithena TM
• Generic Name: Polidocanol
• Dosage Form: Kit
• Marketing Start Date: 2014-07-10
• Marketing Category: NDA / NDA
• Application Number: NDA205098
• Labeler Name: Biocompatibles, Inc.
• Active Ingredient Strength: 0
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 60635-123-01

1 KIT in 1 BOX (60635-123-01) * 1 APPLICATOR in 1 BLISTER PACK > 45 mL in 1 APPLICATOR * 1 CANISTER in 1 POUCH > 303 mL in 1 CANISTER

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

NDC SPL Data Element Entries

NDC 60635-123-01 [60635012301]

Varithena KIT

• Marketing Category: NDA
• Application Number: NDA205098
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-06-22
• Marketing End Date: 2017-01-09
• 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 TM" or generic name "Polidocanol"

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