tranexamic acid

Generic: tranexamic acid

Labeler: provepharm inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler provepharm inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
Provepharm Inc.

Identifiers & Regulatory

Product NDC 81284-612
Product ID 81284-612_9319bf8d-71d6-40da-8ea6-39036da7d192
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212676
Listing Expiration 2026-12-31
Marketing Start 2021-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81284612
Hyphenated Format 81284-612

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 ANDA212676 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (81284-612-10) / 10 mL in 1 VIAL, SINGLE-DOSE (81284-612-00)
source: ndc

Packages (1)

81284-612-10 10 VIAL, SINGLE-DOSE in 1 CARTON (81284-612-10) / 10 mL in 1 VIAL, SINGLE-DOSE (81284-612-00)

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": "9319bf8d-71d6-40da-8ea6-39036da7d192", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["1b8c3500-8e87-4b6e-b6a9-8da5f9c00820"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Provepharm Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (81284-612-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (81284-612-00)", "package_ndc": "81284-612-10", "marketing_start_date": "20210930"}], "brand_name": "tranexamic acid", "product_id": "81284-612_9319bf8d-71d6-40da-8ea6-39036da7d192", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "81284-612", "generic_name": "Tranexamic Acid", "labeler_name": "Provepharm Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tranexamic acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA212676", "marketing_category": "ANDA", "marketing_start_date": "20210930", "listing_expiration_date": "20261231"}