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Nepafenac Ophthalmic Suspension

NAFDAC Reg. No. B4-5603 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Nepafenac Ophthalmic Suspension
NAFDAC number
B4-5603
Active ingredient
Nepafenac
Strength
0.1%
Form
Suspension/Drops
Pack size
1 x 5 mL (in plastic bottle)
Manufacturer
Not listed
Applicant (holder)
Lin-Kabs Pharmaceutical Limited
Approved
28 Sep 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
27 Sep 2026
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Nepafenac Ophthalmic Suspension is on the NAFDAC register with an active registration (B4-5603). 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 Nepafenac Ophthalmic Suspension is used for

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

What it is used for

ILEVRO ® 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery. ILEVRO ® 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery ( 1 ).

Possible side effects

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow Eye, LLC at 1-833-4HARROW or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

Do not use if

ILEVRO ® 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal anti-inflammatory drugs (NSAIDs). Hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDS). ( 4 )

Warnings

Increased bleeding time due to interference with thrombocyte aggregation ( 5.1 ) Delayed healing ( 5.2 ) Corneal effects including keratitis ( 5.3 ) 5.1 Increased Bleeding Time With some NSAIDs including ILEVRO ® 0.3%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery. It is recommended that ILEVRO ® 0.3% be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. …

Pregnancy & breastfeeding

8.1 Pregnancy Teratogenic Effects. Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. …

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

Check your pack of Nepafenac Ophthalmic Suspension

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 Nepafenac Ophthalmic Suspension

What is in Nepafenac Ophthalmic Suspension?

Nepafenac Ophthalmic Suspension contains Nepafenac (0.1%), as suspension/drops, according to its NAFDAC registration record.

Is Nepafenac Ophthalmic Suspension registered with NAFDAC?

Yes. Nepafenac Ophthalmic Suspension is listed on the NAFDAC register under registration number B4-5603, and its registration is active as of 5 November 2026.

Has Nepafenac Ophthalmic Suspension been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Nepafenac Ophthalmic Suspension in our automatically synced alert list.

How can I check that my pack of Nepafenac Ophthalmic Suspension is genuine?

Run a free authenticity scan with the NAFDAC number B4-5603, 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 Nepafenac Ophthalmic Suspension used for?

ILEVRO ® 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery. ILEVRO ® 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery ( 1 ). (Summarised from the official U.S. FDA label for nepafenac. Always follow your doctor or pharmacist.)

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