🇺🇸
United States · US · US:59651-026_8c4f5611-f65b-42c2-8412-e616f149ee90
Amoxicillin and Clavulanate Potassium
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115965102601100 mL in 1 BOTTLE (59651-026-01)
- ndc115965102655150 mL in 1 BOTTLE (59651-026-55)
- ndc11596510267575 mL in 1 BOTTLE (59651-026-75)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A209371
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": {
"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": "59651-026_8c4f5611-f65b-42c2-8412-e616f149ee90",
"productndc": "59651-026",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "209371",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG/5ML;EQ 31.25MG BASE/5ML",
"product_no": "001",
"approval_date": "Apr 19, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG/5ML;EQ 62.5MG BASE/5ML",
"product_no": "002",
"approval_date": "Apr 19, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"proprietary_name": "Amoxicillin and Clavulanate Potassium",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA209371",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20190419",
"active_numerator_strength": "250; 62.5"
}Related drugs
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