iopamidol

Generic: iopamidol

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

Drug Facts

Product Profile

Brand Name iopamidol
Generic Name iopamidol
Labeler slate run pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRATHECAL
Active Ingredients

iopamidol 408 mg/mL

Manufacturer
Slate Run Pharmaceuticals

Identifiers & Regulatory

Product NDC 70436-124
Product ID 70436-124_16308b6e-8a2e-8431-e063-6294a90a986c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215382
Listing Expiration 2026-12-31
Marketing Start 2023-07-20

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 70436124
Hyphenated Format 70436-124

Supplemental Identifiers

UNII
JR13W81H44
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 iopamidol (source: ndc)
Generic Name iopamidol (source: ndc)
Application Number ANDA215382 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 408 mg/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, SINGLE-DOSE (70436-124-33)
  • 20 mL in 1 VIAL, SINGLE-DOSE (70436-124-35)
  • 200 mL in 1 CARTON (70436-124-52)
  • 100 mL in 1 CARTON (70436-124-82)
source: ndc

Packages (4)

70436-124-33 10 mL in 1 VIAL, SINGLE-DOSE (70436-124-33) 70436-124-35 20 mL in 1 VIAL, SINGLE-DOSE (70436-124-35) 70436-124-52 200 mL in 1 CARTON (70436-124-52) 70436-124-82 100 mL in 1 CARTON (70436-124-82)

Ingredients (1)

iopamidol (408 mg/mL)

Linked Drug Pages (1)

iopamidol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL"], "spl_id": "16308b6e-8a2e-8431-e063-6294a90a986c", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["JR13W81H44"], "spl_set_id": ["0b9e0d24-c6ca-4e22-9422-936e9d475eaa"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["Slate Run Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, SINGLE-DOSE (70436-124-33)", "package_ndc": "70436-124-33", "marketing_start_date": "20230720"}, {"sample": false, "description": "20 mL in 1 VIAL, SINGLE-DOSE (70436-124-35)", "package_ndc": "70436-124-35", "marketing_start_date": "20230720"}, {"sample": false, "description": "200 mL in 1 CARTON (70436-124-52)", "package_ndc": "70436-124-52", "marketing_start_date": "20230720"}, {"sample": false, "description": "100 mL in 1 CARTON (70436-124-82)", "package_ndc": "70436-124-82", "marketing_start_date": "20230720"}], "brand_name": "iopamidol", "product_id": "70436-124_16308b6e-8a2e-8431-e063-6294a90a986c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "70436-124", "generic_name": "iopamidol", "labeler_name": "Slate Run Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "iopamidol", "active_ingredients": [{"name": "IOPAMIDOL", "strength": "408 mg/mL"}], "application_number": "ANDA215382", "marketing_category": "ANDA", "marketing_start_date": "20230720", "listing_expiration_date": "20261231"}