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United States · US · US:67877-891_779b70b9-d16c-4421-9e45-7800e947690d
Cephalexin
Orange BookUNIISPLATC J01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeJ01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116787789101100 TABLET in 1 BOTTLE (67877-891-01)
Annotations
UNII (FDA Substance ID)
OBN7UDS42Y
CEPHALEXIN
RxCUI 215948
Orange Book
A218947
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": "67877-891_779b70b9-d16c-4421-9e45-7800e947690d",
"productndc": "67877-891",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218947",
"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": "ANDA218947",
"marketing_category": "ANDA",
"nonproprietary_name": "Cephalexin",
"start_marketing_date": "20241021",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01DB01.
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