🇺🇸
United States · US · US:71205-115_78139082-90f2-4200-bf95-8a46315597ed
Ketotifen Fumarate
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171205115051 BOTTLE, DROPPER in 1 CARTON (71205-115-05) / 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": "71205-115_78139082-90f2-4200-bf95-8a46315597ed",
"productndc": "71205-115",
"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",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA077958",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketotifen Fumarate",
"start_marketing_date": "20071001",
"active_numerator_strength": ".35"
}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.