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United States · US · US:14789-115_2f0e80ab-c6c5-cb03-e063-6394a90a1f92

Tranexamic Acid

Orange BookUNIISPLATC B02AA02

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

Identification

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

Packs · 1

  • ndc11
    1478911505
    10 BAG in 1 CARTON (14789-115-05) / 100 mL in 1 BAG (14789-115-08)

Annotations

UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A216877
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": "14789-115_2f0e80ab-c6c5-cb03-e063-6394a90a1f92",
  "productndc": "14789-115",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216877",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/100ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 16, 2024"
      }
    ],
    "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": "ANDA216877",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tranexamic Acid",
  "start_marketing_date": "20240625",
  "active_numerator_strength": "10"
}

Related drugs

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