tranexamic acid

Generic: tranexamic acid

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

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler remedyrepack inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4089
Product ID 70518-4089_3fa3ef1f-68ef-c73a-e063-6294a90a137a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212360
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184089
Hyphenated Format 70518-4089

Supplemental Identifiers

RxCUI
238720
UNII
6T84R30KC1
NUI
N0000175634 N0000175632

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 CARTON in 1 BOX (70518-4089-0) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4089-1)
source: ndc

Packages (1)

70518-4089-0 10 CARTON in 1 BOX (70518-4089-0) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4089-1)

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": "3fa3ef1f-68ef-c73a-e063-6294a90a137a", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["9d97790f-048b-494d-aa22-5689643a724b"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 BOX (70518-4089-0)  / 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4089-1)", "package_ndc": "70518-4089-0", "marketing_start_date": "20240601"}], "brand_name": "TRANEXAMIC ACID", "product_id": "70518-4089_3fa3ef1f-68ef-c73a-e063-6294a90a137a", "dosage_form": "INJECTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "70518-4089", "generic_name": "tranexamic acid", "labeler_name": "REMEDYREPACK INC.", "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": "20240601", "listing_expiration_date": "20261231"}