🇺🇸
United States · US · US:71335-1417_9b063e20-462a-40fb-a65a-98728e8acea5
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
- ndc11713351417010 TABLET in 1 BOTTLE (71335-1417-0)
- ndc11713351417130 TABLET in 1 BOTTLE (71335-1417-1)
- ndc117133514172120 TABLET in 1 BOTTLE (71335-1417-2)
- ndc11713351417320 TABLET in 1 BOTTLE (71335-1417-3)
- ndc11713351417460 TABLET in 1 BOTTLE (71335-1417-4)
- ndc11713351417590 TABLET in 1 BOTTLE (71335-1417-5)
- ndc1171335141768 TABLET in 1 BOTTLE (71335-1417-6)
- ndc11713351417740 TABLET in 1 BOTTLE (71335-1417-7)
- ndc11713351417815 TABLET in 1 BOTTLE (71335-1417-8)
- ndc11713351417984 TABLET in 1 BOTTLE (71335-1417-9)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A202991
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": "71335-1417_9b063e20-462a-40fb-a65a-98728e8acea5",
"productndc": "71335-1417",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202991",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;5MG",
"product_no": "001",
"approval_date": "Apr 12, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;7.5MG",
"product_no": "002",
"approval_date": "Apr 12, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;10MG",
"product_no": "003",
"approval_date": "Apr 12, 2016"
}
],
"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": "ANDA202991",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
"start_marketing_date": "20160412",
"active_numerator_strength": "325; 5"
}Related drugs
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