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United States · US · US:0406-0124_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
- ndc110406012401100 TABLET in 1 BOTTLE (0406-0124-01)
- ndc110406012405500 TABLET in 1 BOTTLE (0406-0124-05)
- ndc1104060124101000 TABLET in 1 BOTTLE (0406-0124-10)
- ndc1104060124231 TABLET in 1 BLISTER PACK (0406-0124-23)
- ndc110406012462100 TABLET in 1 BLISTER PACK (0406-0124-62)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040405
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": "0406-0124_748bcfb4-7b4c-420c-a9c8-c93fd481f3d9",
"productndc": "0406-0124",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040405",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "001",
"approval_date": "Sep 8, 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": "ANDA040405",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN",
"start_marketing_date": "20000908",
"active_numerator_strength": "325; 7.5"
}Related drugs
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- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgR J General Corporation
- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgSun Pharmaceutical Industries, Inc.
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