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United States · US · US:71205-822_0193c0a4-f595-609c-e063-6294a90aaa68

Indomethacin

Orange BookUNIISPLATC C01EB03

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC01EB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7120582230
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-822-30)
  • ndc11
    7120582260
    60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-822-60)
  • ndc11
    7120582290
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-822-90)

Annotations

UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A201807
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": "71205-822_0193c0a4-f595-609c-e063-6294a90aaa68",
  "productndc": "71205-822",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "201807",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INDOMETHACIN",
  "proprietary_name": "Indomethacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201807",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indomethacin",
  "start_marketing_date": "20150724",
  "active_numerator_strength": "75"
}

Related drugs

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