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United States · US · US:55289-469_34679342-bf84-f9e4-e063-6294a90aae55

INDOMETHACIN

Orange BookUNIISPLATC C01EB03

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC01EB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5528946910
    10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-469-10)

Annotations

UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A079175
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "XXE1CET956",
    "rxcui": "5781",
    "inchikey": "CGIGDMFJXJATDK-UHFFFAOYSA-N",
    "display_name": "INDOMETHACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "009097a5-2c1e-4f5d-8054-896cf896cb3d": {
      "match": "brand_token",
      "title": "INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "17",
      "published_date": "2026-05-28"
    }
  },
  "productid": "55289-469_34679342-bf84-f9e4-e063-6294a90aae55",
  "productndc": "55289-469",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "079175",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Mar 6, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INDOMETHACIN",
  "proprietary_name": "INDOMETHACIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA079175",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indomethacin",
  "start_marketing_date": "20090306",
  "active_numerator_strength": "75"
}

Related drugs

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