tranexamic acid

Generic: tranexamic acid

Labeler: heritage pharmaceuticals labs inc. d/b/a avet pharmaceuticals labs inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler heritage pharmaceuticals labs inc. d/b/a avet pharmaceuticals labs inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 1 g/10mL

Manufacturer
Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.

Identifiers & Regulatory

Product NDC 23155-166
Product ID 23155-166_940fb6bf-5347-4409-91b7-aec36d132a45
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203521
Listing Expiration 2026-12-31
Marketing Start 2014-08-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155166
Hyphenated Format 23155-166

Supplemental Identifiers

RxCUI
238720
UPC
0323155166316
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 ANDA203521 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (23155-166-41) / 10 mL in 1 VIAL, GLASS (23155-166-31)
source: ndc

Packages (1)

23155-166-41 10 VIAL, GLASS in 1 CARTON (23155-166-41) / 10 mL in 1 VIAL, GLASS (23155-166-31)

Ingredients (1)

tranexamic acid (1 g/10mL)

Linked Drug Pages (1)

Tranexamic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "940fb6bf-5347-4409-91b7-aec36d132a45", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0323155166316"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["28ccedba-99cd-49f3-a782-798df5258524"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (23155-166-41)  / 10 mL in 1 VIAL, GLASS (23155-166-31)", "package_ndc": "23155-166-41", "marketing_start_date": "20140813"}], "brand_name": "Tranexamic Acid", "product_id": "23155-166_940fb6bf-5347-4409-91b7-aec36d132a45", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "23155-166", "generic_name": "Tranexamic Acid", "labeler_name": "Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic Acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "1 g/10mL"}], "application_number": "ANDA203521", "marketing_category": "ANDA", "marketing_start_date": "20140813", "listing_expiration_date": "20261231"}