🇺🇸
United States · US · US:71335-2118_24585507-b847-4425-849c-f5d809ecf0b3
Hydrocodone Bitartrate and Acetaminophen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc117133521180120 TABLET in 1 BOTTLE (71335-2118-0)
- ndc11713352118120 TABLET in 1 BOTTLE (71335-2118-1)
- ndc11713352118230 TABLET in 1 BOTTLE (71335-2118-2)
- ndc11713352118340 TABLET in 1 BOTTLE (71335-2118-3)
- ndc11713352118445 TABLET in 1 BOTTLE (71335-2118-4)
- ndc11713352118556 TABLET in 1 BOTTLE (71335-2118-5)
- ndc11713352118660 TABLET in 1 BOTTLE (71335-2118-6)
- ndc11713352118784 TABLET in 1 BOTTLE (71335-2118-7)
- ndc11713352118890 TABLET in 1 BOTTLE (71335-2118-8)
- ndc117133521189100 TABLET in 1 BOTTLE (71335-2118-9)
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": "71335-2118_24585507-b847-4425-849c-f5d809ecf0b3",
"productndc": "71335-2118",
"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": "20181108",
"active_numerator_strength": "325; 10"
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