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United States · US · US:76385-106_948d4259-9d62-4bc7-9149-6961034364bf
KETOTIFEN FUMARATE
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1176385106171 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) / 5 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
HBD503WORO
KETOTIFEN FUMARATE
RxCUI 11404
Orange Book
A204059
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": "76385-106_948d4259-9d62-4bc7-9149-6961034364bf",
"productndc": "76385-106",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "204059",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.025% BASE",
"product_no": "001",
"approval_date": "Jun 1, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "KETOTIFEN FUMARATE",
"proprietary_name": "KETOTIFEN FUMARATE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA204059",
"marketing_category": "ANDA",
"nonproprietary_name": "KETOTIFEN FUMARATE",
"start_marketing_date": "20211015",
"active_numerator_strength": ".25"
}Related drugs
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