🇺🇸
United States · US · US:0536-1252_4d77465a-daa0-b622-e063-6294a90a7d81
Ketotifen Fumarate
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRugby Laboratories
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105361252401 BOTTLE, DROPPER in 1 CARTON (0536-1252-40) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
HBD503WORO
KETOTIFEN FUMARATE
RxCUI 11404
Orange Book
N021996
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": "0536-1252_4d77465a-daa0-b622-e063-6294a90a7d81",
"productndc": "0536-1252",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "021996",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.025% BASE",
"product_no": "001",
"approval_date": "Dec 1, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 0.025% BASE",
"product_no": "002",
"approval_date": "Feb 11, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "KETOTIFEN FUMARATE",
"proprietary_name": "Ketotifen Fumarate",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021996",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Ketotifen Fumarate",
"start_marketing_date": "20200918",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code R06AX17.
Access this data programmatically
Query Ketotifen Fumarate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.