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United States · US · US:63481-629_3cbe384a-10a6-4a65-b305-4a466ceed0b4
PERCOCET
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116348162970100 TABLET in 1 BOTTLE (63481-629-70)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040330
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": {
"ee151649-b52a-0a51-e053-2a95a90a6c35": {
"match": "brand_token",
"title": "PERCOCET (OXYCODONE/APAP) TABLET [DIRECT_RX]",
"spl_version": "2",
"published_date": "2026-03-09"
}
},
"productid": "63481-629_3cbe384a-10a6-4a65-b305-4a466ceed0b4",
"productndc": "63481-629",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040330",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "325MG;2.5MG",
"product_no": "001",
"approval_date": "Jun 25, 1999"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "002",
"approval_date": "Jun 25, 1999"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "003",
"approval_date": "Nov 23, 2001"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "004",
"approval_date": "Nov 23, 2001"
}
],
"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": "PERCOCET",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA040330",
"marketing_category": "ANDA",
"nonproprietary_name": "oxycodone hydrochloride and acetaminophen",
"start_marketing_date": "20011130",
"active_numerator_strength": "325; 10"
}Related drugs
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