Home NDC 60687-750-21 Tranexamic Acid
Product NDC 60687-750
Requested package NDC 60687-750-21
11-digit product format 606870750
Labeler code 60687
Product ID 60687-750_4c258bec-ab80-cb54-e063-6394a90a1893
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tranexamic Acid
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA203256
Marketing category ANDA
Marketing start 2023-10-01
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 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 A203256-001 TRANEXAMIC ACID TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203256-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2016-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2016-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2016-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2016-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2016-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2016-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2016-07-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL 2016-07-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203256-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2016-07-25 cb3db0bc1861…
Observed Orange Book normalized TE history# 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60687-750-11 Tranexamic Acid 1 in 1 BLISTER PACK TABLET 1 3 60687-750-21 Tranexamic Acid 30 in 1 CARTON TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-750 TRANEXAMIC ACID TABLET [AMERICAN HEALTH PACKAGING] 2 Current NDC, 2 package rows 20241030_cbc6f5b3-927e-4a94-8836-dbcd47ef97a8.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 · 3 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 60687-750-21 60687075021 30 BLISTER PACK in 1 CARTON (60687-750-21) / 1 TABLET in 1 BLISTER PACK (60687-750-11) 30 blister pack 2023-10-01 No No Current