NDC 0407-1415

OMNIPAQUE

Iohexol

OMNIPAQUE is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Ge Healthcare Inc.. The primary component is Iohexol.

• Product ID: 0407-1415_1f744058-0ffe-4096-82c1-a665d90ef341
• NDC: 0407-1415
• Product Type: Human Prescription Drug
• Proprietary Name: OMNIPAQUE
• Generic Name: Iohexol
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-04-27
• Marketing Category: NDA / NDA
• Application Number: NDA018956
• Labeler Name: GE Healthcare Inc.
• Substance Name: IOHEXOL
• Active Ingredient Strength: 9 mg/mL
• Pharm Classes: Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0407-1415-09

10 BOTTLE, PLASTIC in 1 BOX (0407-1415-09) > 500 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2018-04-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0407-1415-09 [00407141509]

OMNIPAQUE SOLUTION

• Marketing Category: NDA
• Application Number: NDA018956
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-04-27

Drug Details

Active Ingredients

Ingredient	Strength
IOHEXOL	9 mg/mL

OpenFDA Data

• SPL SET ID: eee15ebe-d349-4497-acef-6abe7a8247fb
• Manufacturer:
  • GE Healthcare Inc.
• UNII:
  • 4419T9MX03

Pharmacological Class

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

NDC Crossover Matching brand name "OMNIPAQUE" or generic name "Iohexol"

NDC	Brand Name	Generic Name
0407-1401	OMNIPAQUE	Iohexol
0407-1411	OMNIPAQUE	Iohexol
0407-1412	OMNIPAQUE	Iohexol
0407-1413	Omnipaque	Iohexol
0407-1414	Omnipaque	Iohexol
0407-1415	OMNIPAQUE	OMNIPAQUE
0407-1416	OMNIPAQUE	OMNIPAQUE