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United States · US · US:71335-2115_9298ad66-e3db-4eec-af82-dfa1eb178abc

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
    7133521150
    8 TABLET in 1 BOTTLE (71335-2115-0)
  • ndc11
    7133521151
    120 TABLET in 1 BOTTLE (71335-2115-1)
  • ndc11
    7133521152
    15 TABLET in 1 BOTTLE (71335-2115-2)
  • ndc11
    7133521153
    20 TABLET in 1 BOTTLE (71335-2115-3)
  • ndc11
    7133521154
    28 TABLET in 1 BOTTLE (71335-2115-4)
  • ndc11
    7133521155
    30 TABLET in 1 BOTTLE (71335-2115-5)
  • ndc11
    7133521156
    40 TABLET in 1 BOTTLE (71335-2115-6)
  • ndc11
    7133521157
    56 TABLET in 1 BOTTLE (71335-2115-7)
  • ndc11
    7133521158
    60 TABLET in 1 BOTTLE (71335-2115-8)
  • ndc11
    7133521159
    90 TABLET in 1 BOTTLE (71335-2115-9)

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": "71335-2115_9298ad66-e3db-4eec-af82-dfa1eb178abc",
  "productndc": "71335-2115",
  "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; 7.5"
}

Related drugs

Other records sharing ATC code N02BE.

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