kit for the preparation of technetium tc 99m mebrofenin

Generic: kit for the preparation of technetium tc 99m mebrofenin

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name kit for the preparation of technetium tc 99m mebrofenin
Generic Name kit for the preparation of technetium tc 99m mebrofenin
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mebrofenin 45 mg/10mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 45567-0455
Product ID 45567-0455_20bf6038-c480-0b7f-e063-6394a90a8d65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078242
Listing Expiration 2026-12-31
Marketing Start 2008-01-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 455670455
Hyphenated Format 45567-0455

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 kit for the preparation of technetium tc 99m mebrofenin (source: ndc)
Generic Name kit for the preparation of technetium tc 99m mebrofenin (source: ndc)
Application Number ANDA078242 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/10mL
source: ndc
Packaging
  • 5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE
  • 30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

45567-0455-1 5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE 45567-0455-2 30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

mebrofenin (45 mg/10mL)

Linked Drug Pages (1)

Kit for the Preparation of Technetium Tc 99m Mebrofenin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "20bf6038-c480-0b7f-e063-6394a90a8d65", "openfda": {"unii": ["7PV0B6ED98"], "spl_set_id": ["11492bd5-2ade-4eb4-a23c-b9be99c0d51a"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "45567-0455-1", "marketing_start_date": "20080129"}, {"sample": false, "description": "30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "45567-0455-2", "marketing_start_date": "20080129"}], "brand_name": "Kit for the Preparation of Technetium Tc 99m Mebrofenin", "product_id": "45567-0455_20bf6038-c480-0b7f-e063-6394a90a8d65", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "45567-0455", "generic_name": "Kit for the Preparation of Technetium Tc 99m Mebrofenin", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kit for the Preparation of Technetium Tc 99m Mebrofenin", "active_ingredients": [{"name": "MEBROFENIN", "strength": "45 mg/10mL"}], "application_number": "ANDA078242", "marketing_category": "ANDA", "marketing_start_date": "20080129", "listing_expiration_date": "20261231"}