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United States · US · US:31722-008_5d30ffab-38a1-411d-94ad-0a15c227d882
Zafirlukast
Orange BookUNIISPLATC R03DC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03DC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11317220080110 BLISTER PACK in 1 CARTON (31722-008-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc113172200805500 TABLET, FILM COATED in 1 BOTTLE (31722-008-05)
- ndc11317220086060 TABLET, FILM COATED in 1 BOTTLE (31722-008-60)
Annotations
UNII (FDA Substance ID)
XZ629S5L50
ZAFIRLUKAST
RxCUI 114970
Orange Book
A212475
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": "31722-008_5d30ffab-38a1-411d-94ad-0a15c227d882",
"productndc": "31722-008",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212475",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Sep 10, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Sep 10, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZAFIRLUKAST",
"proprietary_name": "Zafirlukast",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212475",
"marketing_category": "ANDA",
"nonproprietary_name": "Zafirlukast",
"start_marketing_date": "20200910",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code R03DC01.
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