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
7133501071
21 CAPSULE in 1 BOTTLE (71335-0107-1)
ndc11
7133501072
42 CAPSULE in 1 BOTTLE (71335-0107-2)
ndc11
7133501073
30 CAPSULE in 1 BOTTLE (71335-0107-3)
ndc11
7133501074
60 CAPSULE in 1 BOTTLE (71335-0107-4)
ndc11
7133501075
90 CAPSULE in 1 BOTTLE (71335-0107-5)
ndc11
7133501076
14 CAPSULE in 1 BOTTLE (71335-0107-6)
ndc11
7133501077
20 CAPSULE in 1 BOTTLE (71335-0107-7)

Annotations

UNII (FDA Substance ID)

XXE1CET956

INDOMETHACIN

RxCUI 5781

Orange Book

A091276

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": "71335-0107_e3d83288-9aec-4595-9367-a65cc3e72724",
  "productndc": "71335-0107",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "091276",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Dec 22, 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": "ANDA091276",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indomethacin",
  "start_marketing_date": "20101222",
  "active_numerator_strength": "50"
}

Related drugs

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