tranexamic acid

Generic: tranexamic acid

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-415
Product ID 25021-415_3fd920b8-1b08-4882-9ed4-dd1b5b52af94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207239
Listing Expiration 2026-12-31
Marketing Start 2023-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021415
Hyphenated Format 25021-415

Supplemental Identifiers

RxCUI
238720
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 ANDA207239 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-415-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

25021-415-10 10 VIAL in 1 CARTON (25021-415-10) / 10 mL in 1 VIAL

Ingredients (1)

tranexamic acid (100 mg/mL)

Linked Drug Pages (2)

Tranexamic Acid ndc-match (0.9) Tranexamic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3fd920b8-1b08-4882-9ed4-dd1b5b52af94", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["0277db2d-7c81-4cd0-ac19-fa12b5721428"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-415-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-415-10", "marketing_start_date": "20230715"}], "brand_name": "Tranexamic Acid", "product_id": "25021-415_3fd920b8-1b08-4882-9ed4-dd1b5b52af94", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "25021-415", "generic_name": "Tranexamic Acid", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic Acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA207239", "marketing_category": "ANDA", "marketing_start_date": "20230715", "listing_expiration_date": "20261231"}