🇺🇸
United States · US · US:87063-050_4ca4b03b-efbe-4d32-e063-6394a90af0f3
Hydrocodone Bitartrate and Acetaminophen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 9
- ndc118706305001100 TABLET in 1 BOTTLE (87063-050-01)
- ndc1187063050055 TABLET in 1 BOTTLE (87063-050-05)
- ndc1187063050077 TABLET in 1 BOTTLE (87063-050-07)
- ndc11870630501010 TABLET in 1 BOTTLE (87063-050-10)
- ndc11870630501414 TABLET in 1 BOTTLE (87063-050-14)
- ndc11870630502020 TABLET in 1 BOTTLE (87063-050-20)
- ndc11870630503030 TABLET in 1 BOTTLE (87063-050-30)
- ndc11870630506060 TABLET in 1 BOTTLE (87063-050-60)
- ndc11870630509090 TABLET in 1 BOTTLE (87063-050-90)
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": {
"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": "87063-050_4ca4b03b-efbe-4d32-e063-6394a90af0f3",
"productndc": "87063-050",
"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 Bitartrate and Acetaminophen",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA210211",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
"start_marketing_date": "20180713",
"active_numerator_strength": "325; 7.5"
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