NDC 76381-314

ISOVUE 200

Iopamidol

ISOVUE 200 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: 76381-314_5c4ac062-d59d-f667-f218-1572e3d8cde8
• NDC: 76381-314
• Product Type: Human Prescription Drug
• Proprietary Name: ISOVUE 200
• Generic Name: Iopamidol
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVASCULAR
• Marketing Start Date: 1985-12-31
• Marketing Category: NDA / NDA
• Application Number: NDA018735
• Labeler Name: BIPSO GmbH
• 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: 2019-12-31

Packaging

NDC 76381-314-30

10 VIAL, SINGLE-DOSE in 1 BOX (76381-314-30) > 50 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	408 mg/mL

OpenFDA Data

• SPL SET ID: 764f5085-7ee8-fdba-2c5b-ae6721014a94
• Manufacturer:
  • BIPSO GmbH
• UNII:
  • JR13W81H44

Pharmacological Class

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

NDC Crossover Matching brand name "ISOVUE 200" or generic name "Iopamidol"

NDC	Brand Name	Generic Name
76381-314	ISOVUE 200	ISOVUE 200
0270-1314	ISOVUE	IOPAMIDOL
0270-1315	ISOVUE	IOPAMIDOL
0270-1316	ISOVUE	IOPAMIDOL
0270-1317	ISOVUE	IOPAMIDOL