🇺🇸
United States · US · US:72189-671_4f1b668e-fb85-43a0-e063-6294a90af3ef
Tramadol/APAP
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_rx
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11721896716060 TABLET in 1 BOTTLE (72189-671-60)
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": {
"4e40f55e-1d8e-ce2f-e063-6294a90a7bec": {
"match": "brand_token",
"title": "TRAMADOL/APAP TABLET [DIRECT_RX]",
"spl_version": "2",
"published_date": "2026-04-13"
}
},
"productid": "72189-671_4f1b668e-fb85-43a0-e063-6294a90af3ef",
"productndc": "72189-671",
"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/APAP",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA090485",
"marketing_category": "ANDA",
"nonproprietary_name": "Tramadol/APAP",
"start_marketing_date": "20260330",
"active_numerator_strength": "325; 37.5"
}Related drugs
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