🇺🇸
United States · US · US:0781-1943_047eb353-1ca4-419b-947c-4d418f87c22a
Amoxicillin and Clavulanate Potassium
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11078119433940 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39)
- ndc11078119438228 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A090227
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": "0781-1943_047eb353-1ca4-419b-947c-4d418f87c22a",
"productndc": "0781-1943",
"dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
"orange_book": {
"appl_no": "090227",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "1GM;EQ 62.5MG BASE",
"product_no": "001",
"approval_date": "Apr 21, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM",
"proprietary_name": "Amoxicillin and Clavulanate Potassium",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA090227",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20100421",
"active_numerator_strength": "562.5; 437.5; 62.5"
}Related drugs
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