🇺🇸
United States · US · US:0781-6139_a64b73f7-9181-47db-9150-8ca6d2fbd189
Amoxicillin and Clavulanate Potassium
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110781613948200 mL in 1 BOTTLE, DISPENSING (0781-6139-48)
- ndc110781613954125 mL in 1 BOTTLE, DISPENSING (0781-6139-54)
- ndc11078161395775 mL in 1 BOTTLE, DISPENSING (0781-6139-57)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A065358
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": "0781-6139_a64b73f7-9181-47db-9150-8ca6d2fbd189",
"productndc": "0781-6139",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "065358",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG/5ML;EQ 42.9MG BASE/5ML",
"product_no": "001",
"approval_date": "Aug 13, 2007"
}
],
"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": "ANDA065358",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20070813",
"active_numerator_strength": "600; 42.9"
}Related drugs
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