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United States · US · US:72485-107_49a3cee3-011b-4a23-a732-b5ec1c02c590

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 · 2

  • ndc11
    7248510701
    1 VIAL, GLASS in 1 CARTON (72485-107-01) / 10 mL in 1 VIAL, GLASS
  • ndc11
    7248510710
    10 VIAL, GLASS in 1 CARTON (72485-107-10) / 10 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A206713
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": "72485-107_49a3cee3-011b-4a23-a732-b5ec1c02c590",
  "productndc": "72485-107",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206713",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Jun 27, 2017"
      }
    ],
    "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": "ANDA206713",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TRANEXAMIC ACID",
  "start_marketing_date": "20210611",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code B02AA02.

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