gadoterate meglumine

Generic: gadoterate meglumine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gadoterate meglumine
Generic Name gadoterate meglumine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

gadoterate meglumine 376.9 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-088
Product ID 65219-088_8b9a98ef-bee6-43fc-a39d-2e5a3c226653
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215982
Listing Expiration 2026-12-31
Marketing Start 2022-06-20

Pharmacologic Class

Classes
gadolinium-based contrast agent [epc] magnetic resonance contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219088
Hyphenated Format 65219-088

Supplemental Identifiers

UPC
0365219088066
UNII
L0ND3981AG

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 gadoterate meglumine (source: ndc)
Generic Name gadoterate meglumine (source: ndc)
Application Number ANDA215982 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 376.9 mg/mL
source: ndc
Packaging
  • 6 CARTON in 1 BOX (65219-088-50) / 1 VIAL in 1 CARTON (65219-088-06) / 100 mL in 1 VIAL
source: ndc

Packages (1)

65219-088-50 6 CARTON in 1 BOX (65219-088-50) / 1 VIAL in 1 CARTON (65219-088-06) / 100 mL in 1 VIAL

Ingredients (1)

gadoterate meglumine (376.9 mg/mL)

Linked Drug Pages (1)

Gadoterate Meglumine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8b9a98ef-bee6-43fc-a39d-2e5a3c226653", "openfda": {"upc": ["0365219088066"], "unii": ["L0ND3981AG"], "spl_set_id": ["fbebe7f2-a0c2-4fd5-b421-8fbcbaf46709"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 CARTON in 1 BOX (65219-088-50)  / 1 VIAL in 1 CARTON (65219-088-06)  / 100 mL in 1 VIAL", "package_ndc": "65219-088-50", "marketing_start_date": "20220620"}], "brand_name": "Gadoterate Meglumine", "product_id": "65219-088_8b9a98ef-bee6-43fc-a39d-2e5a3c226653", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "65219-088", "generic_name": "gadoterate meglumine", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gadoterate Meglumine", "active_ingredients": [{"name": "GADOTERATE MEGLUMINE", "strength": "376.9 mg/mL"}], "application_number": "ANDA215982", "marketing_category": "ANDA", "marketing_start_date": "20220620", "listing_expiration_date": "20261231"}