Indomethacin

Orange BookUNIISPLATC C01EB03

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeC01EB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071019587
5 BLISTER PACK in 1 CARTON (70710-1958-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1958-6)

Annotations

UNII (FDA Substance ID)

XXE1CET956

INDOMETHACIN

RxCUI 5781

Orange Book

A216184

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": "RECTAL",
  "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": "70710-1958_472b97d6-5eef-4fc5-8a01-b5466d00715e",
  "productndc": "70710-1958",
  "dosage_form": "SUPPOSITORY",
  "orange_book": {
    "appl_no": "216184",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 2, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INDOMETHACIN",
  "proprietary_name": "Indomethacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216184",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indomethacin",
  "start_marketing_date": "20240415",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code C01EB03.

Access this data programmatically

Query Indomethacin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs