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United States · US · US:71335-0108_938a574e-dc14-4a18-a353-aaf96eb5bf66

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

  • ndc11
    7133501080
    8 TABLET in 1 BOTTLE (71335-0108-0)
  • ndc11
    7133501081
    120 TABLET in 1 BOTTLE (71335-0108-1)
  • ndc11
    7133501082
    15 TABLET in 1 BOTTLE (71335-0108-2)
  • ndc11
    7133501083
    20 TABLET in 1 BOTTLE (71335-0108-3)
  • ndc11
    7133501084
    28 TABLET in 1 BOTTLE (71335-0108-4)
  • ndc11
    7133501085
    30 TABLET in 1 BOTTLE (71335-0108-5)
  • ndc11
    7133501086
    40 TABLET in 1 BOTTLE (71335-0108-6)
  • ndc11
    7133501087
    56 TABLET in 1 BOTTLE (71335-0108-7)
  • ndc11
    7133501088
    60 TABLET in 1 BOTTLE (71335-0108-8)
  • ndc11
    7133501089
    90 TABLET in 1 BOTTLE (71335-0108-9)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A201013
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": "71335-0108_938a574e-dc14-4a18-a353-aaf96eb5bf66",
  "productndc": "71335-0108",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201013",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;7.5MG",
        "product_no": "002",
        "approval_date": "Apr 11, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "003",
        "approval_date": "Apr 11, 2012"
      }
    ],
    "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": "ANDA201013",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
  "start_marketing_date": "20120411",
  "active_numerator_strength": "325; 7.5"
}

Related drugs

Other records sharing ATC code N02BE.

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