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United States · US · US:0517-0960_1a8db732-66d1-443c-9664-08f9e84903f1
Tranexamic Acid
Orange BookUNIISPLATC B02AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeB02AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1105170960011 VIAL, GLASS in 1 CARTON (0517-0960-01) / 10 mL in 1 VIAL, GLASS
- ndc11051709601010 VIAL, GLASS in 1 CARTON (0517-0960-10) / 10 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A201885
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": "0517-0960_1a8db732-66d1-443c-9664-08f9e84903f1",
"productndc": "0517-0960",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "201885",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Aug 10, 2011"
}
],
"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": "ANDA201885",
"marketing_category": "ANDA",
"nonproprietary_name": "tranexamic acid",
"start_marketing_date": "20111115",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code B02AA02.
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