Home NDC 83634-403 tranexamic acid in sodium chloride
Product NDC 83634-403
11-digit product format 836340403
Labeler code 83634
Product ID 83634-403_3de7c58b-1244-4ba9-af17-7a7f318e1255
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tranexamic acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Avenacy Inc.
Application ANDA218896
Marketing category ANDA
Marketing start 2025-09-01
Substance TRANEXAMIC ACID
Active strength 10 mg/mL
Pharmacologic classes Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A218896-001 TRANEXAMIC ACID TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-06-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218896-001 AP
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 2026-02-19 14:30 UTC 2026-02 A218896-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218896-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218896-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-06-02 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218896-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-06-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218896-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218896-001 AP 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218896-001 AP 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218896-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base tranexamic acid in sodium chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRANEXAMIC ACID 10 mg/mL
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 2170286 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83634-403-51 tranexamic acid in sodium chloride 10 in 1 CARTON INJECTION, SOLUTION 10 2 83634-403-82 tranexamic acid in sodium chloride 100 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 100 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83634-403-51 83634040351 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-403-51) / 100 mL in 1 VIAL, SINGLE-DOSE (83634-403-82) 2025-09-01 No No Current 83634-403-82 83634040382 100 mL in 1 VIAL, SINGLE-DOSE 100 ml Historical