isovue-m

Generic: iopamidol

Labeler: bracco diagnostics inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name isovue-m
Generic Name iopamidol
Labeler bracco diagnostics inc
Dosage Form INJECTION, SOLUTION
Routes
INTRATHECAL
Active Ingredients

iopamidol 612 mg/mL

Manufacturer
Bracco Diagnostics Inc

Identifiers & Regulatory

Product NDC 0270-1412
Product ID 0270-1412_07cc86aa-255e-f459-c9c5-747f57811163
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018735
Listing Expiration 2027-12-31
Marketing Start 1985-12-31

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 02701412
Hyphenated Format 0270-1412

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 isovue-m (source: ndc)
Generic Name iopamidol (source: ndc)
Application Number NDA018735 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 612 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1412-15) / 15 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0270-1412-15 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1412-15) / 15 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

iopamidol (612 mg/mL)

Linked Drug Pages (1)

ISOVUE-M ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL"], "spl_id": "07cc86aa-255e-f459-c9c5-747f57811163", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["JR13W81H44"], "spl_set_id": ["11e893d2-0183-4581-b908-c8b7302c7edb"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["Bracco Diagnostics Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1412-15)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0270-1412-15", "marketing_start_date": "19851231"}], "brand_name": "ISOVUE-M", "product_id": "0270-1412_07cc86aa-255e-f459-c9c5-747f57811163", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0270-1412", "generic_name": "IOPAMIDOL", "labeler_name": "Bracco Diagnostics Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOVUE-M", "active_ingredients": [{"name": "IOPAMIDOL", "strength": "612 mg/mL"}], "application_number": "NDA018735", "marketing_category": "NDA", "marketing_start_date": "19851231", "listing_expiration_date": "20271231"}