NDC 0270-1411

ISOVUE-M

Iopamidol

ISOVUE-M is a Intrathecal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bracco Diagnostics Inc. The primary component is Iopamidol.

• Product ID: 0270-1411_5418c5cf-20c3-4f65-9c46-53b0d3a68df9
• NDC: 0270-1411
• Product Type: Human Prescription Drug
• Proprietary Name: ISOVUE-M
• Generic Name: Iopamidol
• Dosage Form: Injection, Solution
• Route of Administration: INTRATHECAL
• Marketing Start Date: 1985-12-31
• Marketing Category: NDA / NDA
• Application Number: NDA018735
• Labeler Name: Bracco Diagnostics Inc
• Substance Name: IOPAMIDOL
• Active Ingredient Strength: 408 mg/mL
• Pharm Classes: Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0270-1411-11

10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1411-11) > 10 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 1985-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0270-1411-11 [00270141111]

ISOVUE-M INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA018735
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1985-12-31

NDC 0270-1411-25 [00270141125]

ISOVUE-M INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA018735
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1985-12-31

Drug Details

Active Ingredients

Ingredient	Strength
IOPAMIDOL	408 mg/mL

OpenFDA Data

• SPL SET ID: 11e893d2-0183-4581-b908-c8b7302c7edb
• Manufacturer:
  • Bracco Diagnostics Inc
• UNII:
  • JR13W81H44

Pharmacological Class

• Radiographic Contrast Agent [EPC]
• X-Ray Contrast Activity [MoA]

NDC Crossover Matching brand name "ISOVUE-M" or generic name "Iopamidol"

NDC	Brand Name	Generic Name
76381-412	ISOVUE-M	ISOVUE-M
76381-411	ISOVUE-M	ISOVUE-M
0270-1411	ISOVUE-M	ISOVUE-M
0270-1412	ISOVUE-M	ISOVUE-M
0270-1314	ISOVUE	IOPAMIDOL
0270-1315	ISOVUE	IOPAMIDOL
0270-1316	ISOVUE	IOPAMIDOL
0270-1317	ISOVUE	IOPAMIDOL