🇺🇸
United States · US · US:64950-373_fa4d198c-5525-42d1-adea-04dcc863788d
Hydrocodone Bitartrate and Acetaminophen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenus Lifesciences Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1164950373044 mL in 1 BOTTLE (64950-373-04)
- ndc116495037316473 mL in 1 BOTTLE (64950-373-16)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040838
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": "64950-373_fa4d198c-5525-42d1-adea-04dcc863788d",
"productndc": "64950-373",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "040838",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG/15ML;7.5MG/15ML",
"product_no": "001",
"approval_date": "May 10, 2013"
}
],
"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/15mL; mg/15mL",
"application_number": "ANDA040838",
"marketing_category": "ANDA",
"nonproprietary_name": "hydrocodone bitartrate and acetaminophen",
"start_marketing_date": "20231015",
"active_numerator_strength": "325; 7.5"
}Related drugs
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