Home NDC 67457-197 Tranexamic Acid
Product NDC 67457-197
11-digit product format 674570197
Labeler code 67457
Product ID 67457-197_a7994e55-1e4d-45bc-bb2c-52b63e4ad408
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tranexamic acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA091657
Marketing category ANDA
Marketing start 2011-11-29
Substance TRANEXAMIC ACID
Active strength 100 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 42 .
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 A091657-001 TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091657-001 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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091657-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2011-11-03 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tranexamic Acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRANEXAMIC ACID 100 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 238720 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 67457-197-00 Tranexamic Acid 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 22 67457-197-10 Tranexamic Acid 10 in 1 PACKAGE INJECTION, SOLUTION 10 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-197 TRANEXAMIC ACID INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 20 Current NDC, Legacy NDC, 2 package rows 20211120_6f033f1e-8c78-4c87-b870-6493944315ff.zip
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 Marketing end Sample Exclude flag Status 67457-197-00 67457019700 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 67457-197-10 67457019710 10 VIAL, SINGLE-DOSE in 1 PACKAGE (67457-197-10) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-197-00) 2011-11-29 0000-00-00 No No Current