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United States · US · US:76420-105_b2ddcdd0-7229-99df-e053-2a95a90a8818
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1176420105011 TABLET, FILM COATED in 1 BOTTLE (76420-105-01)
- ndc1176420105022 TABLET, FILM COATED in 1 BOTTLE (76420-105-02)
- ndc1176420105033 TABLET, FILM COATED in 1 BOTTLE (76420-105-03)
- ndc11764201051010 TABLET, FILM COATED in 1 BOTTLE (76420-105-10)
- ndc11764201053030 TABLET, FILM COATED in 1 BOTTLE (76420-105-30)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A201952
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": "76420-105_b2ddcdd0-7229-99df-e053-2a95a90a8818",
"productndc": "76420-105",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "201952",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "325MG;37.5MG",
"product_no": "001",
"approval_date": "Dec 14, 2012"
}
],
"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": "ANDA201952",
"marketing_category": "ANDA",
"nonproprietary_name": "TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN",
"start_marketing_date": "20121215",
"active_numerator_strength": "325; 37.5"
}Related drugs
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