tranexamic acid

Generic: tranexamic acid

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tranexamic acid 650 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-208
Product ID 82804-208_416cdb61-31fb-4554-835f-a7744aa33b61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218320
Listing Expiration 2026-12-31
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 82804208
Hyphenated Format 82804-208

Supplemental Identifiers

RxCUI
883826
UPC
0382804208159
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 ANDA218320 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (82804-208-15)
source: ndc

Packages (1)

82804-208-15 15 TABLET in 1 BOTTLE (82804-208-15)

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": "416cdb61-31fb-4554-835f-a7744aa33b61", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0382804208159"], "unii": ["6T84R30KC1"], "rxcui": ["883826"], "spl_set_id": ["416cdb61-31fb-4554-835f-a7744aa33b61"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (82804-208-15)", "package_ndc": "82804-208-15", "marketing_start_date": "20240611"}], "brand_name": "TRANEXAMIC ACID", "product_id": "82804-208_416cdb61-31fb-4554-835f-a7744aa33b61", "dosage_form": "TABLET", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "82804-208", "generic_name": "TRANEXAMIC ACID", "labeler_name": "Proficient Rx LP", "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": "20261231"}