tranexamic acid

Generic: tranexamic acid

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tranexamic acid 650 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-772
Product ID 50268-772_48364f64-73b3-8c92-e063-6294a90a8b46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022430
Listing Expiration 2027-12-31
Marketing Start 2022-09-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268772
Hyphenated Format 50268-772

Supplemental Identifiers

RxCUI
883826
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 NDA022430 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX (50268-772-13) / 1 TABLET in 1 BLISTER PACK (50268-772-11)
source: ndc

Packages (1)

50268-772-13 30 BLISTER PACK in 1 BOX (50268-772-13) / 1 TABLET in 1 BLISTER PACK (50268-772-11)

Ingredients (1)

tranexamic acid (650 mg/1)

Linked Drug Pages (1)

Tranexamic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48364f64-73b3-8c92-e063-6294a90a8b46", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["883826"], "spl_set_id": ["e8cdb0d6-9498-2902-e053-2995a90a9de4"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-772-13)  / 1 TABLET in 1 BLISTER PACK (50268-772-11)", "package_ndc": "50268-772-13", "marketing_start_date": "20220916"}], "brand_name": "Tranexamic Acid", "product_id": "50268-772_48364f64-73b3-8c92-e063-6294a90a8b46", "dosage_form": "TABLET", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "50268-772", "generic_name": "Tranexamic Acid", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic Acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "650 mg/1"}], "application_number": "NDA022430", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220916", "listing_expiration_date": "20271231"}