Home NDC 72603-818 TRANEXAMIC ACID
Product NDC 72603-818
11-digit product format 726030818
Labeler code 72603
Product ID 72603-818_4877eacd-fda7-4708-93a5-81052c1d2e14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRANEXAMIC ACID
Dosage form TABLET
Route ORAL
Labeler NorthStar Rx LLC
Application ANDA205133
Marketing category ANDA
Marketing start 2026-08-01
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 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 A205133-001 TRANEXAMIC ACID TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205133-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2015-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205133-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2015-09-21 f41ea6bd6efb…
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72603-818-01 72603081801 30 TABLET in 1 BOTTLE (72603-818-01) 30 tablet 2026-08-01 No No Current