🇺🇸
United States · US · US:42858-104_5a4985b5-92c6-42a6-9279-25601ef4d009
Oxycodone and Acetaminophen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRhodes Pharmaceuticals LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114285810401100 TABLET in 1 BOTTLE, PLASTIC (42858-104-01)
- ndc11428581041010 BLISTER PACK in 1 CARTON (42858-104-10) / 10 TABLET in 1 BLISTER PACK
- ndc114285810450500 TABLET in 1 BOTTLE, PLASTIC (42858-104-50)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A201278
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": "42858-104_5a4985b5-92c6-42a6-9279-25601ef4d009",
"productndc": "42858-104",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "201278",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "001",
"approval_date": "Aug 28, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "002",
"approval_date": "Aug 28, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "003",
"approval_date": "Aug 28, 2014"
}
],
"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": "ANDA201278",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxycodone and Acetaminophen",
"start_marketing_date": "20140828",
"active_numerator_strength": "325; 10"
}Related drugs
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