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United States · US · US:23155-524_c4a0942b-be2c-47ce-a7fc-e031804afb79

Tranexamic Acid

Orange BookUNIISPLATC B02AA02

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

Identification

ManufacturerHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
CountryUS (United States)
ATC codeB02AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2315552441
    10 VIAL, GLASS in 1 CARTON (23155-524-41) / 10 mL in 1 VIAL, GLASS (23155-524-31)

Annotations

UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A203521
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": "23155-524_c4a0942b-be2c-47ce-a7fc-e031804afb79",
  "productndc": "23155-524",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203521",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Aug 12, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRANEXAMIC ACID",
  "proprietary_name": "Tranexamic Acid",
  "active_ingred_unit": "g/10mL",
  "application_number": "ANDA203521",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tranexamic Acid",
  "start_marketing_date": "20140813",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code B02AA02.

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