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United States · US · US:50268-772_48364f64-73b3-8c92-e063-6294a90a8b46

Tranexamic Acid

Orange BookUNIISPLATC B02AA02

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

Identification

ManufacturerAvPAK
CountryUS (United States)
ATC codeB02AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5026877213
    30 BLISTER PACK in 1 BOX (50268-772-13) / 1 TABLET in 1 BLISTER PACK (50268-772-11)

Annotations

UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
N022430
AB
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": "ORAL",
  "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": "50268-772_48364f64-73b3-8c92-e063-6294a90a8b46",
  "productndc": "50268-772",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "022430",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "650MG",
        "product_no": "001",
        "approval_date": "Nov 13, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRANEXAMIC ACID",
  "proprietary_name": "Tranexamic Acid",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022430",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Tranexamic Acid",
  "start_marketing_date": "20220916",
  "active_numerator_strength": "650"
}

Related drugs

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