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United States · US · US:70518-3448_4f09bcc9-4adc-f8ae-e063-6294a90a4c35
Cephalexin
Orange BookUNIISPLATC J01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11705183448320 CAPSULE in 1 BOTTLE, PLASTIC (70518-3448-3)
- ndc11705183448421 CAPSULE in 1 BOTTLE, PLASTIC (70518-3448-4)
- ndc11705183448530 CAPSULE in 1 BOTTLE, PLASTIC (70518-3448-5)
- ndc11705183448614 CAPSULE in 1 BOTTLE, PLASTIC (70518-3448-6)
- ndc11705183448728 CAPSULE in 1 BOTTLE, PLASTIC (70518-3448-7)
Annotations
UNII (FDA Substance ID)
OBN7UDS42Y
CEPHALEXIN
RxCUI 215948
Orange Book
A065229
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": "70518-3448_4f09bcc9-4adc-f8ae-e063-6294a90a4c35",
"productndc": "70518-3448",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "065229",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Nov 25, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "002",
"approval_date": "Nov 25, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEPHALEXIN",
"proprietary_name": "Cephalexin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065229",
"marketing_category": "ANDA",
"nonproprietary_name": "Cephalexin",
"start_marketing_date": "20210721",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01DB01.
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