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United States · US · US:31722-542_349de484-29cd-3e15-e063-6394a90a5aa5

Indomethacin

Orange BookUNIISPLATC C01EB03

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC01EB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    3172254201
    12 BOTTLE in 1 CASE (31722-542-01) / 100 CAPSULE in 1 BOTTLE
  • ndc11
    3172254205
    12 BOTTLE in 1 CASE (31722-542-05) / 500 CAPSULE in 1 BOTTLE
  • ndc11
    3172254210
    12 BOTTLE in 1 CASE (31722-542-10) / 1000 CAPSULE in 1 BOTTLE
  • ndc11
    3172254230
    12 BOTTLE in 1 CASE (31722-542-30) / 30 CAPSULE in 1 BOTTLE

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": "31722-542_349de484-29cd-3e15-e063-6394a90a5aa5",
  "productndc": "31722-542",
  "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": "25"
}

Related drugs

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