🇺🇸
United States · US · US:72189-343_2eaccf77-5ca1-97e7-e063-6394a90a7c39
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
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 · 6
- ndc1172189343088 TABLET in 1 BOTTLE (72189-343-08)
- ndc11721893432020 TABLET in 1 BOTTLE (72189-343-20)
- ndc11721893433030 TABLET in 1 BOTTLE (72189-343-30)
- ndc11721893436060 TABLET in 1 BOTTLE (72189-343-60)
- ndc117218934372120 TABLET in 1 BOTTLE (72189-343-72)
- ndc11721893439090 TABLET in 1 BOTTLE (72189-343-90)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A211487
AAAAAAAA
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": "72189-343_2eaccf77-5ca1-97e7-e063-6394a90a7c39",
"productndc": "72189-343",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211487",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "325MG;2.5MG",
"product_no": "001",
"approval_date": "Nov 7, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "002",
"approval_date": "Nov 7, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "003",
"approval_date": "Nov 7, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "004",
"approval_date": "Nov 7, 2018"
}
],
"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": "ANDA211487",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN",
"start_marketing_date": "20220330",
"active_numerator_strength": "325; 5"
}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.