Indomethacin

Orange BookUNIISPLATC C01EB03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeC01EB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
8576603400
10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-00)
ndc11
8576603401
1 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-01)
ndc11
8576603402
2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-02)
ndc11
8576603407
7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-07)
ndc11
8576603410
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-10)
ndc11
8576603414
14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-14)
ndc11
8576603420
20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-20)
ndc11
8576603430
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-30)
ndc11
8576603460
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-60)
ndc11
8576603490
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-90)

Annotations

UNII (FDA Substance ID)

XXE1CET956

INDOMETHACIN

RxCUI 5781

Orange Book

A201807

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": "85766-034_4e91104f-136a-7fd6-e063-6394a90a1c54",
  "productndc": "85766-034",
  "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"
}

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