🇺🇸
United States · US · US:42571-395_2bd14acf-1437-ec8d-e063-6394a90adc4f
Amoxicillin and clavulanate potassium
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11425713954675 mL in 1 BOTTLE (42571-395-46)
- ndc114257139570125 mL in 1 BOTTLE (42571-395-70)
- ndc114257139577200 mL in 1 BOTTLE (42571-395-77)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A217805
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": "42571-395_2bd14acf-1437-ec8d-e063-6394a90adc4f",
"productndc": "42571-395",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "217805",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG/5ML;EQ 42.9MG BASE/5ML",
"product_no": "001",
"approval_date": "Dec 8, 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": "ANDA217805",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and clavulanate potassium",
"start_marketing_date": "20240401",
"active_numerator_strength": "600; 42.9"
}Related drugs
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