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United States · US · US:69344-102_462a8532-9cea-682f-e063-6394a90a50e4

INDOCIN

Orange BookUNIISPLATC C01EB03

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

Identification

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

Packs · 1

  • ndc11
    6934410233
    30 SUPPOSITORY in 1 BOX (69344-102-33)

Annotations

UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A073314
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": "RECTAL",
  "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": "69344-102_462a8532-9cea-682f-e063-6394a90a50e4",
  "productndc": "69344-102",
  "dosage_form": "SUPPOSITORY",
  "orange_book": {
    "appl_no": "073314",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 31, 1992"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INDOMETHACIN",
  "proprietary_name": "INDOCIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA073314",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indomethacin",
  "start_marketing_date": "19920831",
  "active_numerator_strength": "50"
}

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