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United States · US · US:72485-510_a3468b9f-a1c1-43ca-afc0-5b32c8f58b83

Tranexamic Acid

Orange BookUNIISPLATC B02AA02

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

Identification

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

Packs · 1

  • ndc11
    7248551010
    10 VIAL in 1 CARTON (72485-510-10) / 10 mL in 1 VIAL (72485-510-01)

Annotations

UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A212360
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": "72485-510_a3468b9f-a1c1-43ca-afc0-5b32c8f58b83",
  "productndc": "72485-510",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "212360",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Jul 17, 2019"
      }
    ],
    "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": "ANDA212360",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tranexamic Acid",
  "start_marketing_date": "20240206",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code B02AA02.

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