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United States · US · US:68788-4084_95d70587-2cf2-4e14-8ca3-11b762f1188b
Ketotifen Fumarate Ophthalmic Solution
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168788408451 BOTTLE, DROPPER in 1 CARTON (68788-4084-5) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
HBD503WORO
KETOTIFEN FUMARATE
RxCUI 11404
Orange Book
A077958
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HBD503WORO",
"rxcui": "11404",
"inchikey": "YNQQEYBLVYAWNX-WLHGVMLRSA-N",
"display_name": "KETOTIFEN FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"5196ec5b-42d9-40db-a77a-c00360b8cee6": {
"match": "brand_token",
"title": "KETOTIFEN FUMARATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]",
"spl_version": "3",
"published_date": "2026-05-20"
}
},
"productid": "68788-4084_95d70587-2cf2-4e14-8ca3-11b762f1188b",
"productndc": "68788-4084",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "077958",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.025% BASE",
"product_no": "001",
"approval_date": "Jul 26, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "KETOTIFEN FUMARATE",
"proprietary_name": "Ketotifen Fumarate Ophthalmic Solution",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA077958",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketotifen Fumarate",
"start_marketing_date": "20260227",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code R06AX17.
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