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 65219-082
Product ID 65219-082_f05922b7-99d4-48c7-972a-7966bbbbc3b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215304
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 65219082
Hyphenated Format 65219-082

Supplemental Identifiers

UPC
0365219086017 0365219084013 0365219080015 0365219082019
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 ANDA215304 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 376.9 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 BOX (65219-082-10) / 1 VIAL in 1 CARTON (65219-082-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

65219-082-10 10 CARTON in 1 BOX (65219-082-10) / 1 VIAL in 1 CARTON (65219-082-01) / 10 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": "f05922b7-99d4-48c7-972a-7966bbbbc3b4", "openfda": {"upc": ["0365219086017", "0365219084013", "0365219080015", "0365219082019"], "unii": ["L0ND3981AG"], "spl_set_id": ["e0655aac-9508-4141-94f5-fcca6af1c41d"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 BOX (65219-082-10)  / 1 VIAL in 1 CARTON (65219-082-01)  / 10 mL in 1 VIAL", "package_ndc": "65219-082-10", "marketing_start_date": "20220620"}], "brand_name": "Gadoterate Meglumine", "product_id": "65219-082_f05922b7-99d4-48c7-972a-7966bbbbc3b4", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "65219-082", "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": "ANDA215304", "marketing_category": "ANDA", "marketing_start_date": "20220620", "listing_expiration_date": "20261231"}