Home NDC 72578-220-06 Tranexamic Acid
Product NDC 72578-220
Requested package NDC 72578-220-06
11-digit product format 725780220
Labeler code 72578
Product ID 72578-220_b8613d4e-453f-4f45-82c8-50803881383b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tranexamic Acid
Dosage form TABLET
Route ORAL
Labeler Viona Pharmaceuticals Inc
Application ANDA221213
Marketing category ANDA
Marketing start 2026-11-01
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 45 .
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 A221213-001 TRANEXAMIC ACID TRANEXAMIC ACID 650MG TABLET / ORAL AB 2026-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A221213-001 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 2026-11-14 07:37:17 2026-10 A221213-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2026-10-27 d4dbc9d85df4…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-11-14 07:37:17 2026-10 A221213-001 AB 1 d4dbc9d85df4…
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72578-220-06 72578022006 30 TABLET in 1 BOTTLE (72578-220-06) 30 tablet 2026-11-01 No No Current