Home NDC 42192-605 Tranexamic Acid
Product NDC 42192-605
11-digit product format 421920605
Labeler code 42192
Product ID 42192-605_6dba560b-432d-4781-9845-cf028d1bfe4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tranexamic Acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Acella Pharmaceuticals
Application ANDA202436
Marketing category ANDA
Marketing start 2014-02-11
Marketing end 0000-00-00
Substance TRANEXAMIC ACID
Active strength 100 mg/mL
Pharmacologic classes Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42192-605-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42192-605-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42192-605-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42192-605-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42192-605-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42192-605-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42192-605-10 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42192-605-10 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42192-605-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42192-605-10 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42192-605-10 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42192-605-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 42192-605-10 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 42192-605-10 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 42192-605-10 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 42192-605-10 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 42192-605-10 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 42192-605-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 A202436-001 TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202436-001 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 · 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 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tranexamic Acid TRANEXAMIC ACID Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 4f42a81c-37e3-4b57-8e9a-d42c55bbfc52 2026-05-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202436 application number: ANDA202436