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United States · US · US:71335-2695_c616ecfa-42f7-49a2-898f-5aee4405c607

TRANEXAMIC ACID

Orange BookUNIISPLATC B02AA02

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

Identification

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

Packs · 3

  • ndc11
    7133526951
    8 TABLET in 1 BOTTLE (71335-2695-1)
  • ndc11
    7133526952
    30 TABLET in 1 BOTTLE (71335-2695-2)
  • ndc11
    7133526953
    4 TABLET in 1 BOTTLE (71335-2695-3)

Annotations

UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A218320
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": "71335-2695_c616ecfa-42f7-49a2-898f-5aee4405c607",
  "productndc": "71335-2695",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218320",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "650MG",
        "product_no": "001",
        "approval_date": "Jun 11, 2024"
      }
    ],
    "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": "ANDA218320",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TRANEXAMIC ACID",
  "start_marketing_date": "20240611",
  "active_numerator_strength": "650"
}

Related drugs

Other records sharing ATC code B02AA02.

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