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United States · US · US:76420-754_1bb09c78-f794-4b3b-e063-6394a90a8936
Cephalexin
Orange BookUNIISPLATC J01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeJ01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11764207542828 CAPSULE in 1 BOTTLE, PLASTIC (76420-754-28)
- ndc11764207543030 CAPSULE in 1 BOTTLE, PLASTIC (76420-754-30)
- ndc11764207544040 CAPSULE in 1 BOTTLE, PLASTIC (76420-754-40)
Annotations
UNII (FDA Substance ID)
OBN7UDS42Y
CEPHALEXIN
RxCUI 215948
Orange Book
A090836
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": "76420-754_1bb09c78-f794-4b3b-e063-6394a90a8936",
"productndc": "76420-754",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090836",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Dec 20, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "002",
"approval_date": "Dec 20, 2010"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 333MG BASE",
"product_no": "003",
"approval_date": "Mar 29, 2013"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 750MG BASE",
"product_no": "004",
"approval_date": "Mar 29, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEPHALEXIN",
"proprietary_name": "Cephalexin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090836",
"marketing_category": "ANDA",
"nonproprietary_name": "Cephalexin",
"start_marketing_date": "20190819",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01DB01.
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