NDC 0270-0083

Choletec

Mebrofenin

Choletec is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Bracco Diagnostics Inc. The primary component is Mebrofenin.

Product ID0270-0083_976ddf5c-e1a7-5bff-1af0-4d85c2bb50e7
NDC0270-0083
Product TypeHuman Prescription Drug
Proprietary NameCholetec
Generic NameMebrofenin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1987-01-21
Marketing CategoryNDA / NDA
Application NumberNDA018963
Labeler NameBracco Diagnostics Inc
Substance NameMEBROFENIN
Active Ingredient Strength45 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0270-0083-20

10 VIAL in 1 CARTON (0270-0083-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Marketing Start Date1987-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0270-0083-20 [00270008320]

Choletec INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA018963
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-01-21

Drug Details

Active Ingredients

IngredientStrength
MEBROFENIN45 mg/1

OpenFDA Data

SPL SET ID:fd085485-998d-42a3-879a-b2d96cb8aed7
Manufacturer
UNII

NDC Crossover Matching brand name "Choletec" or generic name "Mebrofenin"

NDCBrand NameGeneric Name
0270-0083CholetecMebrofenin
51808-216MebrofeninMebrofenin

Trademark Results [Choletec]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHOLETEC
CHOLETEC
73352605 1255776 Live/Registered
E. R. Squibb & Sons, Inc.
1982-03-01

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