Home NDC 0270-0083 Choletec
Product NDC 0270-0083
11-digit product format 002700083
Labeler code 0270
Product ID 0270-0083_c9c87a8e-a0ca-2d0b-b547-b901932928c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mebrofenin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Bracco Diagnostics Inc
Application NDA018963
Marketing category NDA
Marketing start 1987-01-21
Substance MEBROFENIN
Active strength 45 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Choletec
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEBROFENIN 45 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 7PV0B6ED98
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0270-0083-20 Choletec 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 10 0270-0083-20 Choletec 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEBROFENIN ACTIVE INGREDIENT 7PV0B6ED98 CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6 MEBROFENIN ACTIVE MOIETY 7PV0B6ED98 CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6 STANNOUS FLUORIDE INACTIVE INGREDIENT 3FTR44B32Q CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-0083 CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 9 Current NDC, Legacy NDC, 2 package rows 20240614_fd085485-998d-42a3-879a-b2d96cb8aed7.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0270-0083-20 00270008320 10 VIAL in 1 CARTON (0270-0083-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 10 vial 1987-01-21 0000-00-00 No No Current