🇺🇸
United States · US · US:69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71e
Amoxicillin and Clavulanate potassium
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116909709808150 mL in 1 BOTTLE (69097-098-08)
- ndc11690970984375 mL in 1 BOTTLE (69097-098-43)
- ndc116909709844100 mL in 1 BOTTLE (69097-098-44)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A065431
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": "69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71e",
"productndc": "69097-098",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "065431",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG/5ML;EQ 62.5MG BASE/5ML",
"product_no": "001",
"approval_date": "Nov 25, 2008"
}
],
"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": "ANDA065431",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20241028",
"active_numerator_strength": "250; 62.5"
}Related drugs
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