🇺🇸
United States · US · US:0093-8675_2faf9b29-5df4-4f3c-84d9-6866f91b87e8
Amoxicillin and Clavulanate Potassium
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110093867574200 mL in 1 BOTTLE (0093-8675-74)
- ndc110093867575125 mL in 1 BOTTLE (0093-8675-75)
- ndc11009386757875 mL in 1 BOTTLE (0093-8675-78)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A065162
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": "0093-8675_2faf9b29-5df4-4f3c-84d9-6866f91b87e8",
"productndc": "0093-8675",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "065162",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "600MG/5ML;EQ 42.9MG BASE/5ML",
"product_no": "001",
"approval_date": "Mar 12, 2004"
}
],
"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": "ANDA065162",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20040923",
"active_numerator_strength": "600; 42.9"
}Related drugs
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