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United States · US · US:39822-1000_41c0f4cf-abe1-fec5-e063-6294a90a9b91

Tranexamic Acid

Orange BookUNIISPLATC B02AA02

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

Identification

ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeB02AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3982210001
    10 VIAL in 1 CARTON (39822-1000-1) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A201580
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6T84R30KC1",
    "rxcui": "10691",
    "inchikey": "GYDJEQRTZSCIOI-LJGSYFOKSA-N",
    "display_name": "TRANEXAMIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "28ccedba-99cd-49f3-a782-798df5258524": {
      "match": "brand_token",
      "title": "TRANEXAMIC ACID INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS LABS INC. D/B/A AVET PHARMACEUTICALS LABS INC.]",
      "spl_version": "21",
      "published_date": "2026-06-01"
    }
  },
  "productid": "39822-1000_41c0f4cf-abe1-fec5-e063-6294a90a9b91",
  "productndc": "39822-1000",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "201580",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Jun 14, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRANEXAMIC ACID",
  "proprietary_name": "Tranexamic Acid",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA201580",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tranexamic Acid",
  "start_marketing_date": "20120518",
  "active_numerator_strength": "100"
}

Related drugs

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