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United States · US · US:0406-0123_748bcfb4-7b4c-420c-a9c8-c93fd481f3d9
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSpecGx LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc110406012301100 TABLET in 1 BOTTLE (0406-0123-01)
- ndc110406012305500 TABLET in 1 BOTTLE (0406-0123-05)
- ndc1104060123101000 TABLET in 1 BOTTLE (0406-0123-10)
- ndc1104060123231 TABLET in 1 BLISTER PACK (0406-0123-23)
- ndc110406012362100 TABLET in 1 BLISTER PACK (0406-0123-62)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040409
AA
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": {
"1f9c1adc-f84f-43de-af5c-d93703aba7f8": {
"match": "brand_token",
"title": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RHODES PHARMACEUTICALS LLC]",
"spl_version": "20",
"published_date": "2026-06-01"
}
},
"productid": "0406-0123_748bcfb4-7b4c-420c-a9c8-c93fd481f3d9",
"productndc": "0406-0123",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040409",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "001",
"approval_date": "Oct 20, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA040409",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN",
"start_marketing_date": "20001020",
"active_numerator_strength": "325; 5"
}Related drugs
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