🇺🇸
United States · US · US:73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb
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
- ndc11730430090150 mL in 1 BOTTLE (73043-009-01)
- ndc11730430090275 mL in 1 BOTTLE (73043-009-02)
- ndc117304300903100 mL in 1 BOTTLE (73043-009-03)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A210416
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": "73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb",
"productndc": "73043-009",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "210416",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG/5ML;EQ 57MG BASE/5ML",
"product_no": "001",
"approval_date": "Dec 11, 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": "ANDA210416",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20241101",
"active_numerator_strength": "400; 57"
}Related drugs
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