🇺🇸
United States · US · US:71297-240_18975386-c292-a0cb-e063-6294a90aed18
Augmentin
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllegis Holdings, LLC
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11712972403475 mL in 1 BOTTLE (71297-240-34)
- ndc117129724035100 mL in 1 BOTTLE (71297-240-35)
- ndc117129724036150 mL in 1 BOTTLE (71297-240-36)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
N050575
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "804826J2HU",
"rxcui": "133008",
"inchikey": "MQXQVCLAUDMCEF-CWLIKTDRSA-N",
"display_name": "AMOXICILLIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"59979859-8c9b-4173-a5e3-2e6312fd9d79": {
"match": "brand_token",
"title": "AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR SUSPENSION [USANTIBIOTICS, LLC\n]",
"spl_version": "4",
"published_date": "2025-01-13"
}
},
"productid": "71297-240_18975386-c292-a0cb-e063-6294a90aed18",
"productndc": "71297-240",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "050575",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "125MG/5ML;EQ 31.25MG BASE/5ML",
"product_no": "001",
"approval_date": "Aug 6, 1984"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "250MG/5ML;EQ 62.5MG BASE/5ML",
"product_no": "002",
"approval_date": "Aug 6, 1984"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"proprietary_name": "Augmentin",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "NDA050575",
"marketing_category": "NDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20230901",
"active_numerator_strength": "125; 31.25"
}Related drugs
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