🇺🇸
United States · US · US:0143-9981_29e9e32b-e9a3-48b5-a1c7-14b3bbe447e5
Amoxicillin and Clavulanate Potassium
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110143998101100 mL in 1 BOTTLE (0143-9981-01)
- ndc11014399815050 mL in 1 BOTTLE (0143-9981-50)
- ndc11014399817575 mL in 1 BOTTLE (0143-9981-75)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A065191
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": "0143-9981_29e9e32b-e9a3-48b5-a1c7-14b3bbe447e5",
"productndc": "0143-9981",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "065191",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG/5ML;EQ 57MG BASE/5ML",
"product_no": "001",
"approval_date": "Jan 25, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG/5ML;EQ 28.5MG BASE/5ML",
"product_no": "002",
"approval_date": "Jan 25, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN; CLAVULANIC ACID",
"proprietary_name": "Amoxicillin and Clavulanate Potassium",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA065191",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20071201",
"active_numerator_strength": "200; 28.5"
}Related drugs
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