tranexamic acid

Generic: tranexamic acid

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler advagen pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tranexamic acid 650 mg/1

Manufacturer
ADVAGEN PHARMA LIMITED

Identifiers & Regulatory

Product NDC 72888-178
Product ID 72888-178_47c8db95-c7ce-fe8c-e063-6294a90a4317
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218320
Listing Expiration 2027-12-31
Marketing Start 2024-06-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888178
Hyphenated Format 72888-178

Supplemental Identifiers

RxCUI
883826
UPC
0372888178301 0372888178011 0372888178059
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 ANDA218320 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72888-178-01)
  • 500 TABLET in 1 BOTTLE (72888-178-05)
  • 30 TABLET in 1 BOTTLE (72888-178-30)
source: ndc

Packages (3)

72888-178-01 100 TABLET in 1 BOTTLE (72888-178-01) 72888-178-05 500 TABLET in 1 BOTTLE (72888-178-05) 72888-178-30 30 TABLET in 1 BOTTLE (72888-178-30)

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": "47c8db95-c7ce-fe8c-e063-6294a90a4317", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0372888178301", "0372888178011", "0372888178059"], "unii": ["6T84R30KC1"], "rxcui": ["883826"], "spl_set_id": ["0a843fa7-1266-4666-b23f-22fd313d24a1"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["ADVAGEN PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72888-178-01)", "package_ndc": "72888-178-01", "marketing_start_date": "20240611"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72888-178-05)", "package_ndc": "72888-178-05", "marketing_start_date": "20240611"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72888-178-30)", "package_ndc": "72888-178-30", "marketing_start_date": "20240611"}], "brand_name": "TRANEXAMIC ACID", "product_id": "72888-178_47c8db95-c7ce-fe8c-e063-6294a90a4317", "dosage_form": "TABLET", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "72888-178", "generic_name": "TRANEXAMIC ACID", "labeler_name": "ADVAGEN PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRANEXAMIC ACID", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "650 mg/1"}], "application_number": "ANDA218320", "marketing_category": "ANDA", "marketing_start_date": "20240611", "listing_expiration_date": "20271231"}