NDC 76381-412

ISOVUE-M

Iopamidol

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

• Product ID: 76381-412_d038c2e6-5270-c2ac-9900-523456ef927c
• NDC: 76381-412
• 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: BIPSO GmbH
• Substance Name: IOPAMIDOL
• Active Ingredient Strength: 612 mg/mL
• Pharm Classes: Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 76381-412-15

10 VIAL, SINGLE-DOSE in 1 PACKAGE (76381-412-15) > 15 mL in 1 VIAL, SINGLE-DOSE

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

Drug Details

Active Ingredients

Ingredient	Strength
IOPAMIDOL	612 mg/mL

OpenFDA Data

• SPL SET ID: 1215a15d-b06b-4d34-b83f-7203a526c52f
• Manufacturer:
  • BIPSO GmbH
• 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