gadoterate meglumine

Generic: gadoterate meglumine

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gadoterate meglumine
Generic Name gadoterate meglumine
Labeler slate run pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

gadoterate meglumine 376.9 mg/mL

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-123
Product ID 70436-123_32f1536f-eb01-305c-e063-6294a90a1855
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218073
Listing Expiration 2026-12-31
Marketing Start 2024-06-28

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 70436123
Hyphenated Format 70436-123

Supplemental Identifiers

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 ANDA218073 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 376.9 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (70436-123-33) / 10 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (70436-123-34) / 15 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (70436-123-35) / 20 mL in 1 VIAL
source: ndc

Packages (4)

70436-123-31 10 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL 70436-123-33 10 VIAL in 1 CARTON (70436-123-33) / 10 mL in 1 VIAL 70436-123-34 10 VIAL in 1 CARTON (70436-123-34) / 15 mL in 1 VIAL 70436-123-35 10 VIAL in 1 CARTON (70436-123-35) / 20 mL in 1 VIAL

Ingredients (1)

gadoterate meglumine (376.9 mg/mL)

Linked Drug Pages (2)

gadoterate meglumine ndc-match (0.9) gadoterate meglumine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "32f1536f-eb01-305c-e063-6294a90a1855", "openfda": {"unii": ["L0ND3981AG"], "spl_set_id": ["85404ca7-dbe7-4d06-b30c-4368dcd33b0b"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70436-123-31)  / 5 mL in 1 VIAL", "package_ndc": "70436-123-31", "marketing_start_date": "20240628"}, {"sample": false, "description": "10 VIAL in 1 CARTON (70436-123-33)  / 10 mL in 1 VIAL", "package_ndc": "70436-123-33", "marketing_start_date": "20240628"}, {"sample": false, "description": "10 VIAL in 1 CARTON (70436-123-34)  / 15 mL in 1 VIAL", "package_ndc": "70436-123-34", "marketing_start_date": "20240628"}, {"sample": false, "description": "10 VIAL in 1 CARTON (70436-123-35)  / 20 mL in 1 VIAL", "package_ndc": "70436-123-35", "marketing_start_date": "20240628"}], "brand_name": "gadoterate meglumine", "product_id": "70436-123_32f1536f-eb01-305c-e063-6294a90a1855", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "70436-123", "generic_name": "gadoterate meglumine", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gadoterate meglumine", "active_ingredients": [{"name": "GADOTERATE MEGLUMINE", "strength": "376.9 mg/mL"}], "application_number": "ANDA218073", "marketing_category": "ANDA", "marketing_start_date": "20240628", "listing_expiration_date": "20261231"}