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United States · US · US:31722-565_349e2ce2-f399-926c-e063-6294a90a9185

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 · 5

  • ndc11
    3172256501
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-01)
  • ndc11
    3172256505
    500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-05)
  • ndc11
    3172256510
    1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-10)
  • ndc11
    3172256530
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-30)
  • ndc11
    3172256560
    60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-60)

Annotations

UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A201807
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": "31722-565_349e2ce2-f399-926c-e063-6294a90a9185",
  "productndc": "31722-565",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "201807",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INDOMETHACIN",
  "proprietary_name": "Indomethacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201807",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indomethacin",
  "start_marketing_date": "20150724",
  "active_numerator_strength": "75"
}

Related drugs

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