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United States · US · US:23635-581_9c646c9c-3074-4250-8191-82ac61b515a4
Roxicodone
In shortageOrange BookUNIISPLATC N02AA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSpecGx LLC
CountryUS (United States)
ATC codeN02AA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc112363558110100 TABLET in 1 BOTTLE, PLASTIC (23635-581-10)
Annotations
UNII (FDA Substance ID)
C1ENJ2TE6C
OXYCODONE HYDROCHLORIDE
RxCUI 82063
Orange Book
N021011
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Oxycodone Hydrochloride Oral Solution
Raw payload (JSON)
{
"unii": {
"unii": "C1ENJ2TE6C",
"rxcui": "82063",
"inchikey": "MUZQPDBAOYKNLO-RKXJKUSZSA-N",
"display_name": "OXYCODONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"5a8157d3-ba20-4abf-b0d4-6ad141b31d63": {
"match": "brand_token",
"title": "ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [SPECGX LLC]",
"spl_version": "30",
"published_date": "2026-04-30"
}
},
"productid": "23635-581_9c646c9c-3074-4250-8191-82ac61b515a4",
"productndc": "23635-581",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "021011",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Aug 31, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Aug 31, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "May 15, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXYCODONE HYDROCHLORIDE",
"shortage_reason": "Oxycodone Hydrochloride Oral Solution",
"shortage_status": "current",
"proprietary_name": "Roxicodone",
"active_ingred_unit": "mg/1",
"application_number": "NDA021011",
"marketing_category": "NDA",
"nonproprietary_name": "oxycodone hydrochloride",
"start_marketing_date": "20000831",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N02AA05.
- GBAbtard 10mg modified-release tabletsEthypharm UK Ltd
- GBAbtard 15mg modified-release tabletsEthypharm UK Ltd
- GBAbtard 20mg modified-release tabletsEthypharm UK Ltd
- GBAbtard 30mg modified-release tabletsEthypharm UK Ltd
- GBAbtard 40mg modified-release tabletsEthypharm UK Ltd
- GBAbtard 5mg modified-release tabletsEthypharm UK Ltd
- GBAbtard 60mg modified-release tabletsEthypharm UK Ltd
- GBAbtard 80mg modified-release tabletsEthypharm UK Ltd
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