Home NDC 72319-028 Tranexamic Acid
Product NDC 72319-028
11-digit product format 723190028
Labeler code 72319
Product ID 72319-028_5569a8fa-e383-ff40-e063-6394a90a456d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tranexamic Acid
Dosage form TABLET
Route ORAL
Labeler i3 Pharmaceuticals, LLC
Application ANDA219702
Marketing category ANDA
Marketing start 2026-06-30
Substance TRANEXAMIC ACID
Active strength 650 mg/1
Pharmacologic classes Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219702-001 TRANEXAMIC ACID TRANEXAMIC ACID 650MG TABLET / ORAL AB 2026-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219702-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A219702-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2026-01-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219702-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2026-01-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219702-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2026-01-26 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219702-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2026-01-26 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tranexamic Acid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRANEXAMIC ACID 650 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6T84R30KC1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 883826 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72319-028-01 72319002801 30 TABLET in 1 BOTTLE, PLASTIC (72319-028-01) 30 tablet 2026-06-30 No No Current