gadoteridol

Generic: gadoteridol

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

Drug Facts

Product Profile

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

gadoteridol 279.3 mg/mL

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-121
Product ID 70436-121_3f886711-cb41-3241-e063-6394a90a5bc7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218749
Listing Expiration 2026-12-31
Marketing Start 2025-02-20

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 70436121
Hyphenated Format 70436-121

Supplemental Identifiers

UNII
0199MV609F
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 gadoteridol (source: ndc)
Generic Name gadoteridol (source: ndc)
Application Number ANDA218749 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 279.3 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-31) / 5 mL in 1 VIAL, SINGLE-DOSE
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-33) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-34) / 15 mL in 1 VIAL, SINGLE-DOSE
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-35) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (4)

70436-121-31 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-31) / 5 mL in 1 VIAL, SINGLE-DOSE 70436-121-33 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-33) / 10 mL in 1 VIAL, SINGLE-DOSE 70436-121-34 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-34) / 15 mL in 1 VIAL, SINGLE-DOSE 70436-121-35 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-35) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gadoteridol (279.3 mg/mL)

Linked Drug Pages (1)

GADOTERIDOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3f886711-cb41-3241-e063-6394a90a5bc7", "openfda": {"nui": ["N0000175862", "N0000180184"], "unii": ["0199MV609F"], "spl_set_id": ["538a70e0-061c-40d2-8447-5b7a4e61a55f"], "pharm_class_epc": ["Paramagnetic Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-31)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70436-121-31", "marketing_start_date": "20250220"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-33)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70436-121-33", "marketing_start_date": "20250220"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-34)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70436-121-34", "marketing_start_date": "20250220"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-35)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70436-121-35", "marketing_start_date": "20250220"}], "brand_name": "GADOTERIDOL", "product_id": "70436-121_3f886711-cb41-3241-e063-6394a90a5bc7", "dosage_form": "INJECTION", "pharm_class": ["Magnetic Resonance Contrast Activity [MoA]", "Paramagnetic Contrast Agent [EPC]"], "product_ndc": "70436-121", "generic_name": "GADOTERIDOL", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GADOTERIDOL", "active_ingredients": [{"name": "GADOTERIDOL", "strength": "279.3 mg/mL"}], "application_number": "ANDA218749", "marketing_category": "ANDA", "marketing_start_date": "20250220", "listing_expiration_date": "20261231"}