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United States · US · US:64380-187_e219b453-57d0-4835-9ac3-4bd73f3b0391
Zafirlukast
Orange BookUNIISPLATC R03DC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeR03DC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11643801870160 TABLET, COATED in 1 BOTTLE (64380-187-01)
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": "64380-187_e219b453-57d0-4835-9ac3-4bd73f3b0391",
"productndc": "64380-187",
"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 AUTHORIZED GENERIC",
"nonproprietary_name": "zafirlukast",
"start_marketing_date": "20220915",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R03DC01.
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