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United States · US · US:59651-839_773eb919-7d48-4ba2-af58-aa169f0ea75f

TRANEXAMIC ACID

Orange BookUNIISPLATC B02AA02

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

Identification

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

Packs · 1

  • ndc11
    5965183930
    30 TABLET in 1 BOTTLE (59651-839-30)

Annotations

UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A205133
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": "59651-839_773eb919-7d48-4ba2-af58-aa169f0ea75f",
  "productndc": "59651-839",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205133",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "650MG",
        "product_no": "001",
        "approval_date": "Sep 21, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRANEXAMIC ACID",
  "proprietary_name": "TRANEXAMIC ACID",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205133",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TRANEXAMIC ACID",
  "start_marketing_date": "20231204",
  "active_numerator_strength": "650"
}

Related drugs

Other records sharing ATC code B02AA02.

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