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United States · US · US:42571-189_45fc1537-9ab6-d1e9-e063-6394a90ab620
Tranexamic Acid
Orange BookUNIISPLATC B02AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeB02AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11425711895710 CARTON in 1 CARTON (42571-189-57) / 1 AMPULE in 1 CARTON (42571-189-56) / 10 mL in 1 AMPULE
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": "42571-189_45fc1537-9ab6-d1e9-e063-6394a90ab620",
"productndc": "42571-189",
"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": "20170801",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code B02AA02.
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