omniscan

Generic: gadodiamide

Labeler: ge healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name omniscan
Generic Name gadodiamide
Labeler ge healthcare inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

gadodiamide 287 mg/mL

Manufacturer
GE Healthcare Inc.

Identifiers & Regulatory

Product NDC 0407-0690
Product ID 0407-0690_dfe2f58c-7a8f-408a-9690-6300a49eda17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020123
Listing Expiration 2026-12-31
Marketing Start 2002-04-19

Pharmacologic Class

Established (EPC)
paramagnetic contrast agent [epc]
Mechanism of Action
magnetic resonance contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04070690
Hyphenated Format 0407-0690

Supplemental Identifiers

UNII
84F6U3J2R6
NUI
N0000175862 N0000180184

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 omniscan (source: ndc)
Generic Name gadodiamide (source: ndc)
Application Number NDA020123 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 287 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL
  • 10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL
  • 10 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL
source: ndc

Packages (3)

0407-0690-10 10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL 0407-0690-15 10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL 0407-0690-20 10 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL

Ingredients (1)

gadodiamide (287 mg/mL)

Linked Drug Pages (1)

OMNISCAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "dfe2f58c-7a8f-408a-9690-6300a49eda17", "openfda": {"nui": ["N0000175862", "N0000180184"], "unii": ["84F6U3J2R6"], "spl_set_id": ["1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a"], "pharm_class_epc": ["Paramagnetic Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["GE Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (0407-0690-10)  / 10 mL in 1 VIAL", "package_ndc": "0407-0690-10", "marketing_start_date": "20020419"}, {"sample": false, "description": "10 VIAL in 1 BOX (0407-0690-15)  / 15 mL in 1 VIAL", "package_ndc": "0407-0690-15", "marketing_start_date": "20020419"}, {"sample": false, "description": "10 VIAL in 1 BOX (0407-0690-20)  / 20 mL in 1 VIAL", "package_ndc": "0407-0690-20", "marketing_start_date": "20020419"}], "brand_name": "OMNISCAN", "product_id": "0407-0690_dfe2f58c-7a8f-408a-9690-6300a49eda17", "dosage_form": "INJECTION", "pharm_class": ["Magnetic Resonance Contrast Activity [MoA]", "Paramagnetic Contrast Agent [EPC]"], "product_ndc": "0407-0690", "generic_name": "gadodiamide", "labeler_name": "GE Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OMNISCAN", "active_ingredients": [{"name": "GADODIAMIDE", "strength": "287 mg/mL"}], "application_number": "NDA020123", "marketing_category": "NDA", "marketing_start_date": "20020419", "listing_expiration_date": "20261231"}