🇺🇸
United States · US · US:72189-191_2be977e6-4cfd-9a64-e063-6294a90a9fc9
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirectRx
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11721891913030 TABLET in 1 BOTTLE (72189-191-30)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A209037
AAAAAA
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": "72189-191_2be977e6-4cfd-9a64-e063-6294a90a9fc9",
"productndc": "72189-191",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209037",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "001",
"approval_date": "Jun 21, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "002",
"approval_date": "Jun 21, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "003",
"approval_date": "Jun 21, 2017"
}
],
"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": "ANDA209037",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN",
"start_marketing_date": "20210915",
"active_numerator_strength": "325; 7.5"
}Related drugs
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