NDC 68180-797

Banzel

Rufinamide Oral Suspension

Banzel is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Rufinamide.

Product ID68180-797_c0d2c9e4-ab01-4809-9f1a-9ad4263d0785
NDC68180-797
Product TypeHuman Prescription Drug
Proprietary NameBanzel
Generic NameRufinamide Oral Suspension
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2022-04-01
Marketing CategoryANDA /
Application NumberANDA213457
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameRUFINAMIDE
Active Ingredient Strength40 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68180-797-01

1 BOTTLE in 1 CARTON (68180-797-01) > 460 mL in 1 BOTTLE
Marketing Start Date2022-04-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Banzel" or generic name "Rufinamide Oral Suspension"

NDCBrand NameGeneric Name
62856-582Banzelrufinamide
62856-583Banzelrufinamide
62856-584Banzelrufinamide
68180-797BanzelRufinamide Oral Suspension

Trademark Results [Banzel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BANZEL
BANZEL
77334627 3613307 Live/Registered
Eisai R&D Management Co., Ltd.
2007-11-20

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