🇺🇸
United States · US · US:63187-084_07437d1c-92eb-437a-8740-24a126006667
Tramadol Hydrochloride and Acetaminophen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11631870843030 TABLET in 1 BOTTLE (63187-084-30)
- ndc11631870846060 TABLET in 1 BOTTLE (63187-084-60)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A090485
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
"unii": {
"unii": "362O9ITL9D",
"rxcui": "161",
"inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
"display_name": "ACETAMINOPHEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a6cbd5de-8ae5-49e3-b89b-e35536b115d8": {
"match": "brand_token",
"title": "TRAMADOL HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "63187-084_07437d1c-92eb-437a-8740-24a126006667",
"productndc": "63187-084",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090485",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "325MG;37.5MG",
"product_no": "001",
"approval_date": "Dec 9, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Tramadol Hydrochloride and Acetaminophen",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA090485",
"marketing_category": "ANDA",
"nonproprietary_name": "Tramadol Hydrochloride and Acetaminophen",
"start_marketing_date": "20091217",
"active_numerator_strength": "325; 37.5"
}Related drugs
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