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United States · US · US:71335-0747_e2ac39f9-9b68-419f-9419-d36fae4e5b5a

Indomethacin

Orange BookUNIISPLATC C01EB03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC01EB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7133507471
    21 CAPSULE in 1 BOTTLE (71335-0747-1)
  • ndc11
    7133507472
    42 CAPSULE in 1 BOTTLE (71335-0747-2)
  • ndc11
    7133507473
    30 CAPSULE in 1 BOTTLE (71335-0747-3)
  • ndc11
    7133507474
    60 CAPSULE in 1 BOTTLE (71335-0747-4)
  • ndc11
    7133507475
    90 CAPSULE in 1 BOTTLE (71335-0747-5)
  • ndc11
    7133507476
    14 CAPSULE in 1 BOTTLE (71335-0747-6)
  • ndc11
    7133507477
    20 CAPSULE in 1 BOTTLE (71335-0747-7)
  • ndc11
    7133507478
    10 CAPSULE in 1 BOTTLE (71335-0747-8)

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": "71335-0747_e2ac39f9-9b68-419f-9419-d36fae4e5b5a",
  "productndc": "71335-0747",
  "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": "20160519",
  "active_numerator_strength": "50"
}

Related drugs

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