tranexamic acid

Generic: tranexamic acid

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-106
Product ID 65145-106_32ed8990-d6ba-4d63-8caf-37d231fa8813
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212360
Listing Expiration 2026-12-31
Marketing Start 2025-01-03

Pharmacologic Class

Established (EPC)
antifibrinolytic agent [epc]
Physiologic Effect
decreased fibrinolysis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145106
Hyphenated Format 65145-106

Supplemental Identifiers

RxCUI
238720
UPC
0365145106018 0365145106100
UNII
6T84R30KC1
NUI
N0000175634 N0000175632

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tranexamic acid (source: ndc)
Generic Name tranexamic acid (source: ndc)
Application Number ANDA212360 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (65145-106-10) / 10 mL in 1 VIAL (65145-106-01)
source: ndc

Packages (1)

65145-106-10 10 VIAL in 1 BOX (65145-106-10) / 10 mL in 1 VIAL (65145-106-01)

Ingredients (1)

tranexamic acid (100 mg/mL)

Linked Drug Pages (1)

Tranexamic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "32ed8990-d6ba-4d63-8caf-37d231fa8813", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0365145106018", "0365145106100"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["6326bdbf-fb2e-451a-a0a0-7d0b59ce5438"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (65145-106-10)  / 10 mL in 1 VIAL (65145-106-01)", "package_ndc": "65145-106-10", "marketing_start_date": "20250103"}], "brand_name": "Tranexamic Acid", "product_id": "65145-106_32ed8990-d6ba-4d63-8caf-37d231fa8813", "dosage_form": "INJECTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "65145-106", "generic_name": "Tranexamic Acid", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic Acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA212360", "marketing_category": "ANDA", "marketing_start_date": "20250103", "listing_expiration_date": "20261231"}