iopamidol

Generic: iopamidol

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

Drug Facts

Product Profile

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

iopamidol 612 mg/mL

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-219
Product ID 70436-219_3a1c5a58-814e-8d80-e063-6394a90ac71d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217134
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

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 70436219
Hyphenated Format 70436-219

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 ANDA217134 (source: ndc)
Routes
INTRAVASCULAR
source: ndc

Resolved Composition

Strengths
  • 612 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-52) / 30 mL in 1 VIAL, SINGLE-DOSE (70436-219-36)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-62) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-219-37)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-82) / 100 mL in 1 VIAL, SINGLE-DOSE (70436-219-40)
source: ndc

Packages (3)

70436-219-52 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-52) / 30 mL in 1 VIAL, SINGLE-DOSE (70436-219-36) 70436-219-62 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-62) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-219-37) 70436-219-82 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-82) / 100 mL in 1 VIAL, SINGLE-DOSE (70436-219-40)

Ingredients (1)

iopamidol (612 mg/mL)

Linked Drug Pages (1)

iopamidol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVASCULAR"], "spl_id": "3a1c5a58-814e-8d80-e063-6394a90ac71d", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["JR13W81H44"], "spl_set_id": ["69e9ab05-88f8-45f9-8bc1-ed33ab1385f0"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-52)  / 30 mL in 1 VIAL, SINGLE-DOSE (70436-219-36)", "package_ndc": "70436-219-52", "marketing_start_date": "20240415"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-62)  / 50 mL in 1 VIAL, SINGLE-DOSE (70436-219-37)", "package_ndc": "70436-219-62", "marketing_start_date": "20240415"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-82)  / 100 mL in 1 VIAL, SINGLE-DOSE (70436-219-40)", "package_ndc": "70436-219-82", "marketing_start_date": "20240415"}], "brand_name": "iopamidol", "product_id": "70436-219_3a1c5a58-814e-8d80-e063-6394a90ac71d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "70436-219", "generic_name": "iopamidol", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "iopamidol", "active_ingredients": [{"name": "IOPAMIDOL", "strength": "612 mg/mL"}], "application_number": "ANDA217134", "marketing_category": "ANDA", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}