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United States · US · US:0065-4011_bed738a0-2943-46e7-a65e-2440dac7971b
Zaditor
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1100654011051 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1100654011062 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER
- ndc1100654011113 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
HBD503WORO
KETOTIFEN FUMARATE
RxCUI 11404
Orange Book
A077200
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": {
"ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f": {
"match": "brand_token",
"title": "ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]",
"spl_version": "13",
"published_date": "2023-12-18"
}
},
"productid": "0065-4011_bed738a0-2943-46e7-a65e-2440dac7971b",
"productndc": "0065-4011",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "077200",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 0.025% BASE",
"product_no": "001",
"approval_date": "Sep 2, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "KETOTIFEN FUMARATE",
"proprietary_name": "Zaditor",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA077200",
"marketing_category": "ANDA",
"nonproprietary_name": "ketotifen fumarate",
"start_marketing_date": "20130108",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code R06AX17.
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