🇺🇸
United States · US · US:81964-003_c310871a-ee00-42f4-b846-cd12cebc39bd
AUGMENTIN ES-600
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUSAntibiotics, LLC
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11819640035175 mL in 1 BOTTLE (81964-003-51)
- ndc118196400354200 mL in 1 BOTTLE (81964-003-54)
- ndc118196400369125 mL in 1 BOTTLE (81964-003-69)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
N050755
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": {
"59979859-8c9b-4173-a5e3-2e6312fd9d79": {
"match": "brand_token",
"title": "AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR SUSPENSION [USANTIBIOTICS, LLC\n]",
"spl_version": "4",
"published_date": "2025-01-13"
}
},
"productid": "81964-003_c310871a-ee00-42f4-b846-cd12cebc39bd",
"productndc": "81964-003",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "050755",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "600MG/5ML;EQ 42.9MG BASE/5ML",
"product_no": "001",
"approval_date": "Jun 22, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"proprietary_name": "AUGMENTIN ES-600",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "NDA050755",
"marketing_category": "NDA",
"nonproprietary_name": "amoxicillin and clavulanate potassium",
"start_marketing_date": "20220715",
"active_numerator_strength": "600; 42.9"
}Related drugs
Other records sharing ATC code J01CA.
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Access this data programmatically
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