🇺🇸
United States · US · US:72189-649_4a188f02-629f-25cf-e063-6394a90a5766
Hydrocodone/APAP
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11721896492020 TABLET in 1 BOTTLE (72189-649-20)
- ndc11721896493030 TABLET in 1 BOTTLE (72189-649-30)
- ndc11721896496060 TABLET in 1 BOTTLE (72189-649-60)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A210211
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": {
"446e9f78-4034-5bb4-e063-6394a90ac739": {
"match": "brand_token",
"title": "HYDROCODONE/APAP TABLET [DIRECT_RX]",
"spl_version": "2",
"published_date": "2026-02-06"
}
},
"productid": "72189-649_4a188f02-629f-25cf-e063-6394a90a5766",
"productndc": "72189-649",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210211",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "001",
"approval_date": "Oct 30, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "002",
"approval_date": "Oct 30, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "003",
"approval_date": "Oct 30, 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/APAP",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA210211",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocodone/APAP",
"start_marketing_date": "20251125",
"active_numerator_strength": "325; 5"
}Related drugs
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