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United States · US · US:25021-418_c81489bf-115d-4b9c-a24d-596d0cd53c84
Tranexamic Acid
Orange BookUNIISPLATC B02AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeB02AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11250214188210 BAG in 1 CARTON (25021-418-82) / 100 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A218599
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": "25021-418_c81489bf-115d-4b9c-a24d-596d0cd53c84",
"productndc": "25021-418",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "218599",
"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": "ANDA218599",
"marketing_category": "ANDA",
"nonproprietary_name": "Tranexamic Acid",
"start_marketing_date": "20240915",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code B02AA02.
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