NDC 0407-1411

OMNIPAQUE

Iohexol

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

Product ID0407-1411_1f744058-0ffe-4096-82c1-a665d90ef341
NDC0407-1411
Product TypeHuman Prescription Drug
Proprietary NameOMNIPAQUE
Generic NameIohexol
Dosage FormInjection, Solution
Route of AdministrationINTRATHECAL; ORAL; RECTAL
Marketing Start Date2004-07-15
Marketing CategoryNDA / NDA
Application NumberNDA018956
Labeler NameGE Healthcare Inc.
Substance NameIOHEXOL
Active Ingredient Strength180 mg/mL
Pharm ClassesRadiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0407-1411-10

10 VIAL, GLASS in 1 BOX (0407-1411-10) > 10 mL in 1 VIAL, GLASS
Marketing Start Date2004-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0407-1411-20 [00407141120]

OMNIPAQUE INJECTION
Marketing CategoryNDA
Application NumberNDA018956
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-07-15

NDC 0407-1411-10 [00407141110]

OMNIPAQUE INJECTION
Marketing CategoryNDA
Application NumberNDA018956
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-07-15

Drug Details

Active Ingredients

IngredientStrength
IOHEXOL180 mg/mL

OpenFDA Data

SPL SET ID:eee15ebe-d349-4497-acef-6abe7a8247fb
Manufacturer
UNII

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"

NDCBrand NameGeneric Name
0407-1401OMNIPAQUEIohexol
0407-1411OMNIPAQUEIohexol
0407-1412OMNIPAQUEIohexol
0407-1413OmnipaqueIohexol
0407-1414OmnipaqueIohexol
0407-1415OMNIPAQUEOMNIPAQUE
0407-1416OMNIPAQUEOMNIPAQUE

Trademark Results [OMNIPAQUE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OMNIPAQUE
OMNIPAQUE
73340246 1207823 Live/Registered
Sterling Drug Inc.
1981-12-07

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