🇺🇸
United States · US · US:73043-008_2d94ce8d-5992-45c0-bf59-a8e12d226462
Amoxicillin and Clavulanate Potassium
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDevatis Inc.
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11730430080175 mL in 1 BOTTLE (73043-008-01)
- ndc117304300802125 mL in 1 BOTTLE (73043-008-02)
- ndc117304300803200 mL in 1 BOTTLE (73043-008-03)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A209351
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": "73043-008_2d94ce8d-5992-45c0-bf59-a8e12d226462",
"productndc": "73043-008",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "209351",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG/5ML;EQ 42.9MG BASE/5ML",
"product_no": "001",
"approval_date": "Sep 13, 2023"
}
],
"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": "ANDA209351",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20241101",
"active_numerator_strength": "600; 42.9"
}Related drugs
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