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United States · US · US:65219-534_63b55787-c021-4399-b16f-a445eaeb8e5b
TRANEXAMIC ACID IN SODIUM CHLORIDE
Orange BookUNIISPLATC B02AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB02AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11652195341024 BAG in 1 CASE (65219-534-10) / 100 mL in 1 BAG (65219-534-01)
Annotations
UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A218242
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": "65219-534_63b55787-c021-4399-b16f-a445eaeb8e5b",
"productndc": "65219-534",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "218242",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1GM/100ML (10MG/ML)",
"product_no": "001",
"approval_date": "Aug 15, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRANEXAMIC ACID",
"proprietary_name": "TRANEXAMIC ACID IN SODIUM CHLORIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218242",
"marketing_category": "ANDA",
"nonproprietary_name": "tranexamic acid",
"start_marketing_date": "20241201",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code B02AA02.
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