🇺🇸
United States · US · US:68084-059_2434193f-6ba4-923d-e063-6394a90aec0c
Zafirlukast
Orange BookUNIISPLATC R03DC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeR03DC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680840592130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-059-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-059-11)
Annotations
UNII (FDA Substance ID)
XZ629S5L50
ZAFIRLUKAST
RxCUI 114970
Orange Book
A090372
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "XZ629S5L50",
"rxcui": "114970",
"inchikey": "YEEZWCHGZNKEEK-UHFFFAOYSA-N",
"display_name": "ZAFIRLUKAST",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"baba507f-6557-4551-815c-9ab6606e4ee1": {
"match": "brand_token",
"title": "ZAFIRLUKAST TABLET, COATED [STRIDES PHARMA SCIENCE LIMITED]",
"spl_version": "7",
"published_date": "2026-03-17"
}
},
"productid": "68084-059_2434193f-6ba4-923d-e063-6394a90aec0c",
"productndc": "68084-059",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090372",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 18, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Nov 18, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZAFIRLUKAST",
"proprietary_name": "Zafirlukast",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090372",
"marketing_category": "ANDA",
"nonproprietary_name": "Zafirlukast",
"start_marketing_date": "20130603",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code R03DC01.
Access this data programmatically
Query Zafirlukast 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.