isovue 370

Generic: iopamidol

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

Drug Facts

Product Profile

Brand Name isovue 370
Generic Name iopamidol
Labeler bracco diagnostics inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

iopamidol 755 mg/mL

Manufacturer
Bracco Diagnostics Inc

Identifiers & Regulatory

Product NDC 0270-1316
Product ID 0270-1316_76846458-2ba4-4a3f-8be0-30aaa45be80d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020327
Listing Expiration 2026-12-31
Marketing Start 2014-06-20

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 02701316
Hyphenated Format 0270-1316

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 370 (source: ndc)
Generic Name iopamidol (source: ndc)
Application Number NDA020327 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 755 mg/mL
source: ndc
Packaging
  • 10 BOTTLE in 1 BOX (0270-1316-45) / 200 mL in 1 BOTTLE
  • 6 BOTTLE in 1 BOX (0270-1316-95) / 500 mL in 1 BOTTLE
source: ndc

Packages (2)

0270-1316-45 10 BOTTLE in 1 BOX (0270-1316-45) / 200 mL in 1 BOTTLE 0270-1316-95 6 BOTTLE in 1 BOX (0270-1316-95) / 500 mL in 1 BOTTLE

Ingredients (1)

iopamidol (755 mg/mL)

Linked Drug Pages (2)

ISOVUE 200, ISOVUE 300, ISOVUE 370, ISOVUE 250 ndc-match (0.9) ISOVUE 300, ISOVUE 370 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "76846458-2ba4-4a3f-8be0-30aaa45be80d", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["JR13W81H44"], "spl_set_id": ["797a11d7-dcd4-43ff-311b-3b48a10da2f2"], "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 BOTTLE in 1 BOX (0270-1316-45)  / 200 mL in 1 BOTTLE", "package_ndc": "0270-1316-45", "marketing_start_date": "20140620"}, {"sample": false, "description": "6 BOTTLE in 1 BOX (0270-1316-95)  / 500 mL in 1 BOTTLE", "package_ndc": "0270-1316-95", "marketing_start_date": "20140620"}], "brand_name": "ISOVUE 370", "product_id": "0270-1316_76846458-2ba4-4a3f-8be0-30aaa45be80d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0270-1316", "generic_name": "IOPAMIDOL", "labeler_name": "Bracco Diagnostics Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOVUE", "brand_name_suffix": "370", "active_ingredients": [{"name": "IOPAMIDOL", "strength": "755 mg/mL"}], "application_number": "NDA020327", "marketing_category": "NDA", "marketing_start_date": "20140620", "listing_expiration_date": "20261231"}