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United States · US · US:69043-009_c71c6d65-8fdd-496e-9338-c70276699886
Cephalexin
Orange BookUNIISPLATC J01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCronus Pharma LLC
CountryUS (United States)
ATC codeJ01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116904300901100 CAPSULE in 1 BOTTLE (69043-009-01)
- ndc116904300905500 CAPSULE in 1 BOTTLE (69043-009-05)
Annotations
UNII (FDA Substance ID)
OBN7UDS42Y
CEPHALEXIN
RxCUI 215948
Orange Book
A065253
ABABAB
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": "69043-009_c71c6d65-8fdd-496e-9338-c70276699886",
"productndc": "69043-009",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "065253",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Nov 16, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "002",
"approval_date": "Nov 16, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 750MG BASE",
"product_no": "003",
"approval_date": "Dec 6, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEPHALEXIN",
"proprietary_name": "Cephalexin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065253",
"marketing_category": "ANDA",
"nonproprietary_name": "Cephalexin",
"start_marketing_date": "20051116",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01DB01.
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