Home NDC 69918-301 Tranexamic Acid
Product NDC 69918-301
11-digit product format 699180301
Labeler code 69918
Product ID 69918-301_7bafece1-f0b8-4852-92ca-fe2bf261be04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tranexamic Acid
Dosage form TABLET
Route ORAL
Labeler Nordic Pharma, Inc.
Application NDA022430
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-03-01
Substance TRANEXAMIC ACID
Active strength 650 mg/1
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 N022430-001 LYSTEDA TRANEXAMIC ACID 650MG TABLET / ORAL AB RLD, RS 2009-11-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022430-001 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.
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 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 8 · 312 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022430-001 7947739 2025-03-04 Drug product 2011-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022430-001 8022106 2025-03-04 U-1182 2011-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022430-001 8273795 2025-03-04 U-1182 2012-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022430-001 8487005 2025-03-04 U-1182 Drug product 2013-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022430-001 8791160 2025-03-04 U-1182 Drug product 2014-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022430-001 8809394 2025-03-04 U-1182 Drug product 2014-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022430-001 8957113 2025-03-04 U-1182 Drug product 2015-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022430-001 9060939 2025-03-04 Drug product 2015-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022430-001 7947739 2025-03-04 Drug product 2011-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022430-001 8022106 2025-03-04 U-1182 2011-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022430-001 8273795 2025-03-04 U-1182 2012-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022430-001 8487005 2025-03-04 U-1182 Drug product 2013-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022430-001 8791160 2025-03-04 U-1182 Drug product 2014-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022430-001 8809394 2025-03-04 U-1182 Drug product 2014-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022430-001 8957113 2025-03-04 U-1182 Drug product 2015-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022430-001 9060939 2025-03-04 Drug product 2015-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022430-001 7947739 2025-03-04 Drug product 2011-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022430-001 8022106 2025-03-04 U-1182 2011-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022430-001 8273795 2025-03-04 U-1182 2012-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022430-001 8487005 2025-03-04 U-1182 Drug product 2013-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022430-001 8791160 2025-03-04 U-1182 Drug product 2014-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022430-001 8809394 2025-03-04 U-1182 Drug product 2014-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022430-001 8957113 2025-03-04 U-1182 Drug product 2015-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022430-001 9060939 2025-03-04 Drug product 2015-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022430-001 7947739 2025-03-04 Drug product 2011-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022430-001 8022106 2025-03-04 U-1182 2011-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022430-001 8273795 2025-03-04 U-1182 2012-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022430-001 8487005 2025-03-04 U-1182 Drug product 2013-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022430-001 8791160 2025-03-04 U-1182 Drug product 2014-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022430-001 8809394 2025-03-04 U-1182 Drug product 2014-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022430-001 8957113 2025-03-04 U-1182 Drug product 2015-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022430-001 9060939 2025-03-04 Drug product 2015-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022430-001 7947739 2025-03-04 Drug product 2011-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022430-001 8022106 2025-03-04 U-1182 2011-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022430-001 8273795 2025-03-04 U-1182 2012-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022430-001 8487005 2025-03-04 U-1182 Drug product 2013-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022430-001 8791160 2025-03-04 U-1182 Drug product 2014-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022430-001 8809394 2025-03-04 U-1182 Drug product 2014-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022430-001 8957113 2025-03-04 U-1182 Drug product 2015-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022430-001 9060939 2025-03-04 Drug product 2015-06-23 03ed91905a0d…
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69918-301-30 Tranexamic Acid 30 in 1 BOTTLE TABLET 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69918-301 TRANEXAMIC ACID TABLET [AMRING PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20221223_031bf7c2-3b07-469d-bc5a-31fc6238e25f.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 · 2 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 69918-301-30 69918030130 30 TABLET in 1 BOTTLE (69918-301-30) 30 tablet 2016-03-01 0000-00-00 No No Current