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United States · US · US:82804-106_88347743-e869-4266-835f-599e7c957d00
Cephalexin
Orange BookUNIISPLATC J01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11828041061414 CAPSULE in 1 BOTTLE (82804-106-14)
- ndc11828041061515 CAPSULE in 1 BOTTLE (82804-106-15)
- ndc11828041062020 CAPSULE in 1 BOTTLE (82804-106-20)
- ndc11828041062828 CAPSULE in 1 BOTTLE (82804-106-28)
- ndc11828041063030 CAPSULE in 1 BOTTLE (82804-106-30)
- ndc11828041064040 CAPSULE in 1 BOTTLE (82804-106-40)
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": "82804-106_88347743-e869-4266-835f-599e7c957d00",
"productndc": "82804-106",
"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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