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United States · US · US:0406-0376_84925071-325f-4e10-a767-378cbed0e59c

Hydrocodone Bitartrate and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSpecGx LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0406037601
    100 TABLET in 1 BOTTLE (0406-0376-01)
  • ndc11
    0406037605
    500 TABLET in 1 BOTTLE (0406-0376-05)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A206718
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": "0406-0376_84925071-325f-4e10-a767-378cbed0e59c",
  "productndc": "0406-0376",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206718",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;5MG",
        "product_no": "001",
        "approval_date": "Mar 31, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;7.5MG",
        "product_no": "002",
        "approval_date": "Mar 31, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;10MG",
        "product_no": "003",
        "approval_date": "Mar 31, 2017"
      }
    ],
    "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": "ANDA206718",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
  "start_marketing_date": "20170331",
  "active_numerator_strength": "300; 5"
}

Related drugs

Other records sharing ATC code N02BE.

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