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United States · US · US:42291-971_3b3c7fd6-2d93-6df8-e063-6294a90a841f
Zafirlukast
Orange BookUNIISPLATC R03DC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvKARE
CountryUS (United States)
ATC codeR03DC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11422919716060 TABLET, COATED in 1 BOTTLE (42291-971-60)
Annotations
UNII (FDA Substance ID)
XZ629S5L50
ZAFIRLUKAST
RxCUI 114970
Orange Book
N020547
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": "42291-971_3b3c7fd6-2d93-6df8-e063-6294a90a841f",
"productndc": "42291-971",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "020547",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Sep 26, 1996"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "003",
"approval_date": "Sep 17, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZAFIRLUKAST",
"proprietary_name": "Zafirlukast",
"active_ingred_unit": "mg/1",
"application_number": "NDA020547",
"marketing_category": "NDA",
"nonproprietary_name": "zafirlukast",
"start_marketing_date": "20230405",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code R03DC01.
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