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Omnipaque 300 mg/mL Injection

NAFDAC Reg. No. B4-0329 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Omnipaque 300 mg/mL Injection
NAFDAC number
B4-0329
Active ingredient
Iohexol
Strength
300 mg (Iodine)/mL
Form
Solution for injection
Pack size
50 mL x 10's; 100 mL x 10's (in bottles)
Manufacturer
Not listed
Applicant (holder)
Fensyl MHP Consulting Limited
Approved
30 Jan 2025
Status
Active View on NAFDAC ↗
Registration valid to
29 Jan 2030
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Omnipaque 300 mg/mL Injection is on the NAFDAC register with an active registration (B4-0329). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Omnipaque 300 mg/mL Injection is used for

From the official U.S. FDA label for iohexol, the active ingredient registered with NAFDAC.

Boxed warning: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the OMNIPAQUE iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. …
What it is used for

OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. ( 1 ) 1.1 Intrathecal Procedures ‡ OMNIPAQUE is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older CT cisternography in adults and pediatric patients aged 2 weeks and older 1.2 Intra-arterial Procedures ‡ OMNIPAQUE is indicated for: Cardiac ventriculography in adults and pediatric patients Aortography including studies of aorta and its branches in adults and pediatric patients …

Possible side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Intrathecal Administration of OMNIPAQUE Injection 140 mg Iodine/mL and 350 mg Iodine/mL [see Warnings and Precautions (5.1) ] Risks Associated with Parenteral Administration of OMNIPAQUE Oral Solution [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Acute Kidney Injury [see Warnings and Precautions (5.4) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.5) ] Thromboembolic Events [ see Warnings and Precautions (5.6) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precauti …

Do not use if

OMNIPAQUE for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm. …

Warnings

Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.3 ) Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.4 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.5 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications (4) ]. There are no data with iohexol use in pregnant women to inform any drug-associated risks. Iohexol crosses the placenta and reaches fetal tissues in small amounts ( see Data ) . …

Storage

OMNIPAQUE Injection: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. May be stored in a contrast media warmer for up to one month, not to exceed 37°C (98.6°F). …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Omnipaque 300 mg/mL Injection

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Omnipaque 300 mg/mL Injection

What is in Omnipaque 300 mg/mL Injection?

Omnipaque 300 mg/mL Injection contains Iohexol (300 mg (Iodine)/mL), as solution for injection, according to its NAFDAC registration record.

Is Omnipaque 300 mg/mL Injection registered with NAFDAC?

Yes. Omnipaque 300 mg/mL Injection is listed on the NAFDAC register under registration number B4-0329, and its registration is active as of 5 November 2026.

Has Omnipaque 300 mg/mL Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Omnipaque 300 mg/mL Injection in our automatically synced alert list.

How can I check that my pack of Omnipaque 300 mg/mL Injection is genuine?

Run a free authenticity scan with the NAFDAC number B4-0329, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Omnipaque 300 mg/mL Injection used for?

OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. ( 1 ) 1.1 Intrathecal Procedures ‡ OMNIPAQUE is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged (Summarised from the official U.S. FDA label for iohexol. Always follow your doctor or pharmacist.)

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