🇺🇸
United States · US · US:72189-367_2c4c9fa2-4c33-c1f5-e063-6294a90a4706
Amoxicillin/Clav Pot Oral Susp
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172189367325 mL in 1 BOTTLE (72189-367-32)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A201090
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": {
"3b4f868d-6a3e-8276-e063-6294a90a6457": {
"match": "brand_token",
"title": "AMOXICILLIN/CLAV POT TABLET, FILM COATED [DIRECT_RX]",
"spl_version": "1",
"published_date": "2025-08-04"
}
},
"productid": "72189-367_2c4c9fa2-4c33-c1f5-e063-6294a90a4706",
"productndc": "72189-367",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "201090",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG/5ML;EQ 28.5MG BASE/5ML",
"product_no": "001",
"approval_date": "Dec 20, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG/5ML;EQ 57MG BASE/5ML",
"product_no": "002",
"approval_date": "Dec 20, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"proprietary_name": "Amoxicillin/Clav Pot Oral Susp",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA201090",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin/Clav Pot Oral Susp",
"start_marketing_date": "20220808",
"active_numerator_strength": "400; 57"
}Related drugs
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