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United States · US · US:71205-215_057302f7-9a50-42f4-8f96-ce23f409bc4c

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 · 4

  • ndc11
    7120521520
    20 CAPSULE in 1 BOTTLE (71205-215-20)
  • ndc11
    7120521530
    30 CAPSULE in 1 BOTTLE (71205-215-30)
  • ndc11
    7120521560
    60 CAPSULE in 1 BOTTLE (71205-215-60)
  • ndc11
    7120521590
    90 CAPSULE in 1 BOTTLE (71205-215-90)

Annotations

UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A091240
ABAB
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": "71205-215_057302f7-9a50-42f4-8f96-ce23f409bc4c",
  "productndc": "71205-215",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "091240",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Apr 12, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INDOMETHACIN",
  "proprietary_name": "Indomethacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091240",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indomethacin",
  "start_marketing_date": "20111101",
  "active_numerator_strength": "25"
}

Related drugs

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