🇺🇸
United States · US · US:71205-347_b53c68fe-b3a3-4a62-b75b-cb831ef1a81f
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 · 6
- ndc11712053471212 TABLET in 1 BOTTLE (71205-347-12)
- ndc11712053471515 TABLET in 1 BOTTLE (71205-347-15)
- ndc11712053472020 TABLET in 1 BOTTLE (71205-347-20)
- ndc11712053473030 TABLET in 1 BOTTLE (71205-347-30)
- ndc11712053476060 TABLET in 1 BOTTLE (71205-347-60)
- ndc11712053479090 TABLET in 1 BOTTLE (71205-347-90)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A207419
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": "71205-347_b53c68fe-b3a3-4a62-b75b-cb831ef1a81f",
"productndc": "71205-347",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207419",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;2.5MG",
"product_no": "001",
"approval_date": "Mar 22, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "002",
"approval_date": "Mar 22, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "003",
"approval_date": "Mar 22, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "004",
"approval_date": "Mar 22, 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": "ANDA207419",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxycodone and Acetaminophen",
"start_marketing_date": "20170411",
"active_numerator_strength": "325; 10"
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