Indomethacin

Orange BookUNIISPLATC C01EB03

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC01EB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7133515681
21 CAPSULE in 1 BOTTLE (71335-1568-1)
ndc11
7133515682
42 CAPSULE in 1 BOTTLE (71335-1568-2)
ndc11
7133515683
30 CAPSULE in 1 BOTTLE (71335-1568-3)
ndc11
7133515684
60 CAPSULE in 1 BOTTLE (71335-1568-4)
ndc11
7133515685
90 CAPSULE in 1 BOTTLE (71335-1568-5)
ndc11
7133515686
14 CAPSULE in 1 BOTTLE (71335-1568-6)
ndc11
7133515687
20 CAPSULE in 1 BOTTLE (71335-1568-7)

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": "71335-1568_a78e0fc3-6693-4308-82ed-11084d6d5d62",
  "productndc": "71335-1568",
  "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"
}

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