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United States · US · US:69238-1120_b77a2557-2013-46ce-8d87-a25f17be5b89

Oxaprozin

In shortageOrange BookUNIISPLATC M01AE12

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeM01AE12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6923811201
    100 TABLET in 1 BOTTLE (69238-1120-1)
  • ndc11
    6923811205
    500 TABLET in 1 BOTTLE (69238-1120-5)

Annotations

UNII (FDA Substance ID)
MHJ80W9LRB
OXAPROZIN
RxCUI 32613
Orange Book
A208633
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Oxaprozin Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "MHJ80W9LRB",
    "rxcui": "32613",
    "inchikey": "OFPXSFXSNFPTHF-UHFFFAOYSA-N",
    "display_name": "OXAPROZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e881dca6-004e-1c3e-e053-2a95a90a02ab": {
      "match": "brand_token",
      "title": "OXAPROZIN TABLET, FILM COATED [ST MARY'S MEDICAL PARK PHARMACY]",
      "spl_version": "4",
      "published_date": "2026-05-25"
    }
  },
  "productid": "69238-1120_b77a2557-2013-46ce-8d87-a25f17be5b89",
  "productndc": "69238-1120",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208633",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "May 4, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXAPROZIN",
  "shortage_reason": "Oxaprozin Tablet",
  "shortage_status": "current",
  "proprietary_name": "Oxaprozin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208633",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxaprozin",
  "start_marketing_date": "20170504",
  "active_numerator_strength": "600"
}

Related drugs

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