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United States · US · US:87063-058_45973812-ad2c-0c60-e063-6394a90a9ddc
Amoxicillin
Orange BookUNIISPLATC J01CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerASCLEMED USA INC.
CountryUS (United States)
ATC codeJ01CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc118706305801100 mL in 1 BOTTLE (87063-058-01)
- ndc11870630585050 mL in 1 BOTTLE (87063-058-50)
- ndc11870630587575 mL in 1 BOTTLE (87063-058-75)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
N050760
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": "87063-058_45973812-ad2c-0c60-e063-6394a90a9ddc",
"productndc": "87063-058",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "050760",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Apr 15, 1999"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Apr 15, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN",
"proprietary_name": "Amoxicillin",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA050760",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Amoxicillin",
"start_marketing_date": "20240401",
"active_numerator_strength": "400"
}Related drugs
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- GBAlmodan 125mg/5ml syrupTeva UK Ltd
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- GBAmix 250 capsulesAshbourne Pharmaceuticals Ltd
- GBAmix 250 oral suspensionAshbourne Pharmaceuticals Ltd
Access this data programmatically
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