NDC 46783-121

Asclera

Polidocanol

Asclera is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Merz North America, Inc. The primary component is Polidocanol.

• Product ID: 46783-121_1781730d-b81e-4e88-8218-b07b854e03cb
• NDC: 46783-121
• Product Type: Human Prescription Drug
• Proprietary Name: Asclera
• Generic Name: Polidocanol
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA021201
• Labeler Name: Merz North America, Inc
• Substance Name: POLIDOCANOL
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Sclerosing Agent [EPC],Sclerosing Activity [MoA],Vascular Sclerosing Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 46783-121-52

2 mL in 1 AMPULE (46783-121-52)

• Marketing Start Date: 2010-06-01
• Marketing End Date: 2022-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46783-121-52 [46783012152]

Asclera INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021201
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-06-01

Drug Details

Active Ingredients

Ingredient	Strength
POLIDOCANOL	.005 g/mL

OpenFDA Data

• SPL SET ID: 90550274-6605-44de-8c25-c5591080270f
• Manufacturer:
  • Merz North America, Inc
• UNII:
  • 0AWH8BFG9A
• RxNorm Concept Unique ID - RxCUI:
  • 968177
  • 968183
  • 968181
  • 968173
• UPC Code:
  • 0346783121526
  • 0346783221523

Pharmacological Class

• Sclerosing Agent [EPC]
• Sclerosing Activity [MoA]
• Vascular Sclerosing Activity [PE]

NDC Crossover Matching brand name "Asclera" 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