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United States · US · US:63187-705_cf14c5ce-0aa3-4511-9db0-7d5aa995f04d

Trezix

In shortageOrange BookUNIIATC N02BE

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6318770500
    100 CAPSULE in 1 BOTTLE (63187-705-00)
  • ndc11
    6318770530
    30 CAPSULE in 1 BOTTLE (63187-705-30)
  • ndc11
    6318770560
    60 CAPSULE in 1 BOTTLE (63187-705-60)
  • ndc11
    6318770572
    120 CAPSULE in 1 BOTTLE (63187-705-72)
  • ndc11
    6318770590
    90 CAPSULE in 1 BOTTLE (63187-705-90)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A204785
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",
  "productid": "63187-705_cf14c5ce-0aa3-4511-9db0-7d5aa995f04d",
  "productndc": "63187-705",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204785",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "320.5MG;30MG;16MG",
        "product_no": "001",
        "approval_date": "Nov 26, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Trezix",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA204785",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetaminophen, caffeine, dihydrocodeine bitartrate",
  "start_marketing_date": "20141201",
  "active_numerator_strength": "320.5; 30; 16"
}

Related drugs

Other records sharing ATC code N02BE.

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