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United States · US · US:68788-8538_cabeccb5-a7a9-4906-90f5-70af57054fa6
Cephalexin
Orange BookUNIISPLATC J01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 9
- ndc11687888538112 CAPSULE in 1 BOTTLE (68788-8538-1)
- ndc11687888538220 CAPSULE in 1 BOTTLE (68788-8538-2)
- ndc11687888538330 CAPSULE in 1 BOTTLE (68788-8538-3)
- ndc11687888538440 CAPSULE in 1 BOTTLE (68788-8538-4)
- ndc1168788853856 CAPSULE in 1 BOTTLE (68788-8538-5)
- ndc11687888538660 CAPSULE in 1 BOTTLE (68788-8538-6)
- ndc11687888538721 CAPSULE in 1 BOTTLE (68788-8538-7)
- ndc11687888538828 CAPSULE in 1 BOTTLE (68788-8538-8)
- ndc11687888538914 CAPSULE in 1 BOTTLE (68788-8538-9)
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": "68788-8538_cabeccb5-a7a9-4906-90f5-70af57054fa6",
"productndc": "68788-8538",
"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": "20231019",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01DB01.
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