choletec

Generic: mebrofenin

Labeler: bracco diagnostics inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name choletec
Generic Name mebrofenin
Labeler bracco diagnostics inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mebrofenin 45 mg/1

Manufacturer
Bracco Diagnostics Inc

Identifiers & Regulatory

Product NDC 0270-0083
Product ID 0270-0083_c9c87a8e-a0ca-2d0b-b547-b901932928c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018963
Listing Expiration 2026-12-31
Marketing Start 1987-01-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02700083
Hyphenated Format 0270-0083

Supplemental Identifiers

UNII
7PV0B6ED98

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name choletec (source: ndc)
Generic Name mebrofenin (source: ndc)
Application Number NDA018963 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0270-0083-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

0270-0083-20 10 VIAL in 1 CARTON (0270-0083-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

mebrofenin (45 mg/1)

Linked Drug Pages (1)

Choletec ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c9c87a8e-a0ca-2d0b-b547-b901932928c8", "openfda": {"unii": ["7PV0B6ED98"], "spl_set_id": ["fd085485-998d-42a3-879a-b2d96cb8aed7"], "manufacturer_name": ["Bracco Diagnostics Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0270-0083-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "0270-0083-20", "marketing_start_date": "19870121"}], "brand_name": "Choletec", "product_id": "0270-0083_c9c87a8e-a0ca-2d0b-b547-b901932928c8", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "0270-0083", "generic_name": "Mebrofenin", "labeler_name": "Bracco Diagnostics Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Choletec", "active_ingredients": [{"name": "MEBROFENIN", "strength": "45 mg/1"}], "application_number": "NDA018963", "marketing_category": "NDA", "marketing_start_date": "19870121", "listing_expiration_date": "20261231"}