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United States · US · US:68180-440_78aee1aa-f859-489e-98b5-78af55b92374
cephalexin
Orange BookUNIISPLATC J01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116818044001100 mL in 1 BOTTLE (68180-440-01)
- ndc116818044002200 mL in 1 BOTTLE (68180-440-02)
Annotations
UNII (FDA Substance ID)
OBN7UDS42Y
CEPHALEXIN
RxCUI 215948
Orange Book
A065234
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": "68180-440_78aee1aa-f859-489e-98b5-78af55b92374",
"productndc": "68180-440",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "065234",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 125MG BASE/5ML",
"product_no": "001",
"approval_date": "Aug 17, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE/5ML",
"product_no": "002",
"approval_date": "Aug 17, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEPHALEXIN",
"proprietary_name": "cephalexin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA065234",
"marketing_category": "ANDA",
"nonproprietary_name": "Cephalexin",
"start_marketing_date": "20170821",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code J01DB01.
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