iohexol

Generic: iohexol

Labeler: amneal pharmaceuticals private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name iohexol
Generic Name iohexol
Labeler amneal pharmaceuticals private limited
Dosage Form INJECTION, SOLUTION
Routes
INTRA-ARTICULAR INTRATHECAL INTRAVASCULAR INTRAVENOUS ORAL RECTAL
Active Ingredients

iohexol 300 mg/mL

Manufacturer
Amneal Pharmaceuticals Private Limited

Identifiers & Regulatory

Product NDC 80830-2468
Product ID 80830-2468_b15bb51d-2cc7-407b-9b31-878ca1c67ee2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217737
Listing Expiration 2027-12-31
Marketing Start 2025-11-13

Pharmacologic Class

Established (EPC)
radiographic contrast agent [epc]
Mechanism of Action
x-ray contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 808302468
Hyphenated Format 80830-2468

Supplemental Identifiers

UNII
4419T9MX03
NUI
N0000180185 N0000010258

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 iohexol (source: ndc)
Generic Name iohexol (source: ndc)
Application Number ANDA217737 (source: ndc)
Routes
INTRA-ARTICULAR INTRATHECAL INTRAVASCULAR INTRAVENOUS ORAL RECTAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/mL
source: ndc
Packaging
  • 10 BOTTLE, PLASTIC in 1 CARTON (80830-2468-2) / 100 mL in 1 BOTTLE, PLASTIC (80830-2468-1)
source: ndc

Packages (1)

80830-2468-2 10 BOTTLE, PLASTIC in 1 CARTON (80830-2468-2) / 100 mL in 1 BOTTLE, PLASTIC (80830-2468-1)

Ingredients (1)

iohexol (300 mg/mL)

Linked Drug Pages (1)

Iohexol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTICULAR", "INTRATHECAL", "INTRAVASCULAR", "INTRAVENOUS", "ORAL", "RECTAL"], "spl_id": "b15bb51d-2cc7-407b-9b31-878ca1c67ee2", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["4419T9MX03"], "spl_set_id": ["ff9456ef-c45a-450d-9004-a684af2bcc59"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE, PLASTIC in 1 CARTON (80830-2468-2)  / 100 mL in 1 BOTTLE, PLASTIC (80830-2468-1)", "package_ndc": "80830-2468-2", "marketing_start_date": "20251113"}], "brand_name": "Iohexol", "product_id": "80830-2468_b15bb51d-2cc7-407b-9b31-878ca1c67ee2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "80830-2468", "generic_name": "Iohexol", "labeler_name": "Amneal Pharmaceuticals Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Iohexol", "active_ingredients": [{"name": "IOHEXOL", "strength": "300 mg/mL"}], "application_number": "ANDA217737", "marketing_category": "ANDA", "marketing_start_date": "20251113", "listing_expiration_date": "20271231"}