🇺🇸
United States · US · US:68083-160_3756c37f-5de9-49d4-a756-89cbd5c237e7
Tranexamic acid
Orange BookUNIISPLATC B02AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeB02AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680831601010 VIAL in 1 CARTON (68083-160-10) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
A207239
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": "68083-160_3756c37f-5de9-49d4-a756-89cbd5c237e7",
"productndc": "68083-160",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "207239",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Feb 13, 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": "ANDA207239",
"marketing_category": "ANDA",
"nonproprietary_name": "Tranexamic acid",
"start_marketing_date": "20170222",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code B02AA02.
Access this data programmatically
Query Tranexamic acid and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.