🇺🇸
United States · US · US:0406-0378_84925071-325f-4e10-a767-378cbed0e59c
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 · 2
- ndc110406037801100 TABLET in 1 BOTTLE (0406-0378-01)
- ndc110406037805500 TABLET in 1 BOTTLE (0406-0378-05)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A206718
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": "0406-0378_84925071-325f-4e10-a767-378cbed0e59c",
"productndc": "0406-0378",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206718",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "300MG;5MG",
"product_no": "001",
"approval_date": "Mar 31, 2017"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "300MG;7.5MG",
"product_no": "002",
"approval_date": "Mar 31, 2017"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "300MG;10MG",
"product_no": "003",
"approval_date": "Mar 31, 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": "ANDA206718",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
"start_marketing_date": "20170331",
"active_numerator_strength": "300; 10"
}Related drugs
Other records sharing ATC code N02BE.
- 🇺🇸24-7 Life BY 7-ELEVEN Nighttime Cold and FluLil' Drug Store products, Inc.
- 🇺🇸Aacetaminophen and IbuprofenGRANULES USA, INC.
- 🇺🇸AcetaminophenRAONBIO CORP
- 🇺🇸Acetaminophen , Aspirin and CaffeineSoftgel Healthcare Pvt Ltd
- 🇺🇸Acetaminophen , Caffeine and pyrilamine maleateSoftgel Healthcare Pvt Ltd
- 🇺🇸Acetaminophen , Caffeine and pyrilamine maleateSoftgel Healthcare Pvt Ltd
- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgR J General Corporation
- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgSun Pharmaceutical Industries, Inc.
Access this data programmatically
Query Hydrocodone Bitartrate and Acetaminophen and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.