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United States · US · US:68788-8209_5ddd80af-1ce9-4995-b1e5-0b0faec69859
Amoxicillin
Orange BookUNIISPLATC J01CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Phamraceuticals Inc.
CountryUS (United States)
ATC codeJ01CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11687888209221 CAPSULE in 1 BOTTLE (68788-8209-2)
- ndc11687888209330 CAPSULE in 1 BOTTLE (68788-8209-3)
- ndc11687888209440 CAPSULE in 1 BOTTLE (68788-8209-4)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A065271
ABAB
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": "68788-8209_5ddd80af-1ce9-4995-b1e5-0b0faec69859",
"productndc": "68788-8209",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "065271",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Nov 9, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Nov 9, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN",
"proprietary_name": "Amoxicillin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065271",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin",
"start_marketing_date": "20220908",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01CA04.
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- CAAG-AMOXICILLINANGITA PHARMA INC.
- DKAgeniprimNordic Prime ApS
- DKAgeniprimNordic Prime ApS
- GBAlmodan 125mg/5ml syrupTeva UK Ltd
- GBAmix 125 oral suspensionAshbourne Pharmaceuticals Ltd
- GBAmix 250 capsulesAshbourne Pharmaceuticals Ltd
- GBAmix 250 oral suspensionAshbourne Pharmaceuticals Ltd
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