NDC 52584-411

ISOVUE-M 200

Iopamidol

ISOVUE-M 200 is a Intrathecal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc.. The primary component is Iopamidol.

• Product ID: 52584-411_ca95a1e5-fe0b-437f-b643-86e0bb6fe999
• NDC: 52584-411
• Product Type: Human Prescription Drug
• Proprietary Name: ISOVUE-M 200
• Generic Name: Iopamidol
• Dosage Form: Injection, Solution
• Route of Administration: INTRATHECAL
• Marketing Start Date: 2010-11-05
• Marketing Category: NDA / NDA
• Application Number: NDA018735
• Labeler Name: General Injectables & Vaccines, Inc.
• Substance Name: IOPAMIDOL
• Active Ingredient Strength: 408 mg/mL
• Pharm Classes: Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC SPL Data Element Entries

NDC 52584-411-11 [52584041111]

ISOVUE-M 200 INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA018735
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-11-05
• Marketing End Date: 2017-01-17
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
IOPAMIDOL	408 mg/mL

OpenFDA Data

• SPL SET ID: 60979ac0-024e-4dc8-9a84-c9195093c08d
• Manufacturer:
  • General Injectables & Vaccines, Inc.
• UNII:
  • JR13W81H44

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
52584-411	ISOVUE-M 200	ISOVUE-M 200
0270-1314	ISOVUE	IOPAMIDOL
0270-1315	ISOVUE	IOPAMIDOL
0270-1316	ISOVUE	IOPAMIDOL
0270-1317	ISOVUE	IOPAMIDOL