🇺🇸
United States · US · US:10702-194_4a169a07-a8cd-ada4-e063-6394a90ac7d2
Hydrocodone Bitartrate and Acetaminophen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKVK-Tech, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc111070219401100 TABLET in 1 BOTTLE (10702-194-01)
- ndc11107021940330 TABLET in 1 BOTTLE (10702-194-03)
- ndc1110702194101000 TABLET in 1 BOTTLE (10702-194-10)
- ndc111070219450500 TABLET in 1 BOTTLE (10702-194-50)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A209036
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": "10702-194_4a169a07-a8cd-ada4-e063-6394a90ac7d2",
"productndc": "10702-194",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209036",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;5MG",
"product_no": "001",
"approval_date": "Jun 21, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;7.5MG",
"product_no": "002",
"approval_date": "Jun 21, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;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": "ANDA209036",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
"start_marketing_date": "20170622",
"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.