🇺🇸
United States · US · US:63187-721_b6da114d-fc88-4f72-9055-a963b4625f25
Oxycodone and Acetaminophen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11631877211515 TABLET in 1 BOTTLE (63187-721-15)
- ndc11631877212020 TABLET in 1 BOTTLE (63187-721-20)
- ndc11631877213030 TABLET in 1 BOTTLE (63187-721-30)
- ndc11631877216060 TABLET in 1 BOTTLE (63187-721-60)
- ndc11631877219090 TABLET in 1 BOTTLE (63187-721-90)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040778
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": "63187-721_b6da114d-fc88-4f72-9055-a963b4625f25",
"productndc": "63187-721",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040778",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "001",
"approval_date": "Nov 27, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "002",
"approval_date": "Jun 27, 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": "ANDA040778",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxycodone and Acetaminophen",
"start_marketing_date": "20071127",
"active_numerator_strength": "325; 10"
}Related drugs
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