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United States · US · US:59651-784_e46059e1-3ce9-4a3c-80ce-464b140600ce
Cephalexin
Orange BookUNIISPLATC J01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115965178401100 TABLET, FILM COATED in 1 BOTTLE (59651-784-01)
Annotations
UNII (FDA Substance ID)
OBN7UDS42Y
CEPHALEXIN
RxCUI 215948
Orange Book
A218817
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "OBN7UDS42Y",
"rxcui": "215948",
"inchikey": "AVGYWQBCYZHHPN-CYJZLJNKSA-N",
"display_name": "CEPHALEXIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4ecf9314-76e2-c270-e063-6294a90ad8db": {
"match": "brand_token",
"title": "CEPHALEXIN CAPSULE [NORTHWIND HEALTH COMPANY, LLC]",
"spl_version": "2",
"published_date": "2026-05-25"
}
},
"productid": "59651-784_e46059e1-3ce9-4a3c-80ce-464b140600ce",
"productndc": "59651-784",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218817",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Sep 27, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "002",
"approval_date": "Sep 27, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEPHALEXIN",
"proprietary_name": "Cephalexin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218817",
"marketing_category": "ANDA",
"nonproprietary_name": "Cephalexin",
"start_marketing_date": "20240927",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01DB01.
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