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United States · US · US:69344-101_58959f55-f324-4433-97fc-c3b1b7c199be

Indocin

Orange BookUNIISPLATC C01EB03

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

Identification

ManufacturerZyla Life Sciences US LLC
CountryUS (United States)
ATC codeC01EB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6934410101
    1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
N018332
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": {
    "3b36645c-de5e-4263-ae06-2f6ff6a9add2": {
      "match": "brand_token",
      "title": "INDOCIN (INDOMETHACIN) SUPPOSITORY [ZYLA LIFE SCIENCES US INC.]",
      "spl_version": "6",
      "published_date": "2025-12-19"
    }
  },
  "productid": "69344-101_58959f55-f324-4433-97fc-c3b1b7c199be",
  "productndc": "69344-101",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "018332",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG/5ML",
        "product_no": "001",
        "approval_date": "Oct 10, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INDOMETHACIN",
  "proprietary_name": "Indocin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA018332",
  "marketing_category": "NDA",
  "nonproprietary_name": "indomethacin",
  "start_marketing_date": "20190204",
  "active_numerator_strength": "25"
}

Related drugs

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