NDC 76381-315

ISOVUE 300

Iopamidol

ISOVUE 300 is a Intravascular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bipso Gmbh. The primary component is Iopamidol.

• Product ID: 76381-315_31076157-8a24-15d8-2f7d-343ddf017bff
• NDC: 76381-315
• Product Type: Human Prescription Drug
• Proprietary Name: ISOVUE 300
• Generic Name: Iopamidol
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVASCULAR
• Marketing Start Date: 1994-10-12
• Marketing Category: NDA / NDA
• Application Number: NDA020327
• 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 76381-315-98

6 BOTTLE in 1 BOX (76381-315-98) > 500 mL in 1 BOTTLE

• Marketing Start Date: 1994-10-12
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

Active Ingredients

Ingredient	Strength
IOPAMIDOL	612 mg/mL

OpenFDA Data

• SPL SET ID: 4ec262e0-be4d-6f15-f36f-355b193c8374
• Manufacturer:
  • BIPSO GmbH
• UNII:
  • JR13W81H44

Pharmacological Class

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

NDC Crossover Matching brand name "ISOVUE 300" or generic name "Iopamidol"

NDC	Brand Name	Generic Name
76381-315	ISOVUE 300	ISOVUE 300
0270-1314	ISOVUE	IOPAMIDOL
0270-1315	ISOVUE	IOPAMIDOL
0270-1316	ISOVUE	IOPAMIDOL
0270-1317	ISOVUE	IOPAMIDOL