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United States · US · US:0406-0522_38cc2423-8e75-4007-b224-75aa920582d7
OXYCODONE AND ACETAMINOPHEN
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSpecGx LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc110406052201100 TABLET in 1 BOTTLE (0406-0522-01)
- ndc110406052205500 TABLET in 1 BOTTLE (0406-0522-05)
- ndc1104060522231 TABLET in 1 BLISTER PACK (0406-0522-23)
- ndc110406052262100 TABLET in 1 BLISTER PACK (0406-0522-62)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040545
AAAA
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": "0406-0522_38cc2423-8e75-4007-b224-75aa920582d7",
"productndc": "0406-0522",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040545",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "001",
"approval_date": "Jun 30, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "002",
"approval_date": "Jun 30, 2004"
}
],
"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": "ANDA040545",
"marketing_category": "ANDA",
"nonproprietary_name": "oxycodone hydrochloride and acetaminophen",
"start_marketing_date": "20040630",
"active_numerator_strength": "325; 7.5"
}Related drugs
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