🇺🇸
United States · US · US:87063-034_44677216-216d-f82c-e063-6294a90a3dca
OXYCODONE 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 · 7
- ndc118706303401100 TABLET in 1 BOTTLE (87063-034-01)
- ndc118706303405500 TABLET in 1 BOTTLE (87063-034-05)
- ndc11870630341010 TABLET in 1 BOTTLE (87063-034-10)
- ndc11870630342020 TABLET in 1 BOTTLE (87063-034-20)
- ndc11870630343030 TABLET in 1 BOTTLE (87063-034-30)
- ndc11870630346060 TABLET in 1 BOTTLE (87063-034-60)
- ndc11870630349090 TABLET in 1 BOTTLE (87063-034-90)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A207510
AAAAAA
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": "87063-034_44677216-216d-f82c-e063-6294a90a3dca",
"productndc": "87063-034",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207510",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "001",
"approval_date": "Mar 21, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "002",
"approval_date": "Mar 21, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "003",
"approval_date": "Mar 21, 2018"
}
],
"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": "ANDA207510",
"marketing_category": "ANDA",
"nonproprietary_name": "oxycodone and acetaminophen",
"start_marketing_date": "20190601",
"active_numerator_strength": "325; 10"
}Related drugs
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