🇺🇸
United States · US · US:81964-575_3854c6ad-10f7-dae3-e063-6294a90ae00a
AMOXICILLIN AND CLAVULANATE POTASSIUM
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUSAntibiotics, LLC
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118196457583180 TABLET, COATED in 1 BOTTLE (81964-575-83)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
N050720
AB
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": {
"263a2902-f85c-46b6-8d5b-8c99f5c4b706": {
"match": "brand_token",
"title": "AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "81964-575_3854c6ad-10f7-dae3-e063-6294a90ae00a",
"productndc": "81964-575",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "050720",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "875MG;EQ 125MG BASE",
"product_no": "001",
"approval_date": "Feb 13, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"proprietary_name": "AMOXICILLIN AND CLAVULANATE POTASSIUM",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA050720",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "amoxicillin and clavulanate potassium",
"start_marketing_date": "20250702",
"active_numerator_strength": "875; 125"
}Related drugs
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