🇺🇸
United States · US · US:72245-193_502384f0-4ffd-5d16-e063-6394a90ad304
Nalocet
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerForte Bio-Pharma LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11722451930330 TABLET in 1 BOTTLE, PLASTIC (72245-193-03)
- ndc117224519310100 TABLET in 1 BOTTLE, PLASTIC (72245-193-10)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040608
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": {
"f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be": {
"match": "brand_token",
"title": "NALOCET (OXYCODONE AND ACETAMINOPHEN) TABLET [FORTE BIO-PHARMA LLC]",
"spl_version": "8",
"published_date": "2026-04-27"
}
},
"productid": "72245-193_502384f0-4ffd-5d16-e063-6394a90ad304",
"productndc": "72245-193",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040608",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "300MG;2.5MG",
"product_no": "001",
"approval_date": "Dec 30, 2005"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "300MG;5MG",
"product_no": "002",
"approval_date": "Dec 30, 2005"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "300MG;7.5MG",
"product_no": "003",
"approval_date": "Dec 30, 2005"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "300MG;10MG",
"product_no": "004",
"approval_date": "Dec 30, 2005"
}
],
"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": "Nalocet",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA040608",
"marketing_category": "ANDA",
"nonproprietary_name": "oxycodone and acetaminophen",
"start_marketing_date": "20180523",
"active_numerator_strength": "300; 2.5"
}Related drugs
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