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United States · US · US:55111-626_b5fb9efb-3369-e1f9-384c-bd22e8ecad92
Zafirlukast
Orange BookUNIISPLATC R03DC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddys Laboratories Limited
CountryUS (United States)
ATC codeR03DC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115511162601100 TABLET, FILM COATED in 1 BOTTLE (55111-626-01)
- ndc115511162605500 TABLET, FILM COATED in 1 BOTTLE (55111-626-05)
- ndc11551116263030 TABLET, FILM COATED in 1 BOTTLE (55111-626-30)
- ndc11551116266060 TABLET, FILM COATED in 1 BOTTLE (55111-626-60)
- ndc11551116267810 BLISTER PACK in 1 CARTON (55111-626-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-626-79)
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": "55111-626_b5fb9efb-3369-e1f9-384c-bd22e8ecad92",
"productndc": "55111-626",
"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": "20101118",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code R03DC01.
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