🇺🇸
United States · US · US:43386-492_5e566e5f-2fef-4d70-8cfe-c24b13659b8e
Oxycodone and Acetaminophen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A204407
AAAAAAAA
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": {
"27124cdf-a3e8-474c-9c1e-6fa48f6ddc05": {
"match": "brand_token",
"title": "OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-06-01"
}
},
"productid": "43386-492_5e566e5f-2fef-4d70-8cfe-c24b13659b8e",
"productndc": "43386-492",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204407",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;2.5MG",
"product_no": "001",
"approval_date": "Feb 24, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "002",
"approval_date": "Feb 24, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "003",
"approval_date": "Feb 24, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "004",
"approval_date": "Feb 24, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Oxycodone and Acetaminophen",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA204407",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxycodone and Acetaminophen",
"start_marketing_date": "20170224",
"active_numerator_strength": "325; 7.5"
}Related drugs
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