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United States · US · US:59651-291_8bdb47c5-9d19-4d59-94c8-62c117525e7f
Zafirlukast
Orange BookUNIISPLATC R03DC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeR03DC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11596512916060 TABLET, FILM COATED in 1 BOTTLE (59651-291-60)
Annotations
UNII (FDA Substance ID)
XZ629S5L50
ZAFIRLUKAST
RxCUI 114970
Orange Book
A213163
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": "59651-291_8bdb47c5-9d19-4d59-94c8-62c117525e7f",
"productndc": "59651-291",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213163",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 27, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Nov 27, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZAFIRLUKAST",
"proprietary_name": "Zafirlukast",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213163",
"marketing_category": "ANDA",
"nonproprietary_name": "Zafirlukast",
"start_marketing_date": "20231127",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R03DC01.
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