Back to search
🇺🇸

United States · US · US:65162-506_083ef389-551a-48c5-9a92-f16fb6270ae4

Indomethacin

Orange BookUNIISPLATC C01EB03

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeC01EB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6516250603
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03)
  • ndc11
    6516250606
    60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06)
  • ndc11
    6516250609
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09)
  • ndc11
    6516250610
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10)
  • ndc11
    6516250611
    1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11)
  • ndc11
    6516250650
    500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50)

Annotations

UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A091549
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": "65162-506_083ef389-551a-48c5-9a92-f16fb6270ae4",
  "productndc": "65162-506",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "091549",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Dec 1, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INDOMETHACIN",
  "proprietary_name": "Indomethacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091549",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indomethacin",
  "start_marketing_date": "20101206",
  "active_numerator_strength": "75"
}

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.