Home NDC 50090-4530-0 Tranexamic Acid
Product NDC 50090-4530
Requested package NDC 50090-4530-0
11-digit product format 500904530
Labeler code 50090
Product ID 50090-4530_7c84633d-aabd-4012-a600-ae678213e1d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tranexamic Acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler A-S Medication Solutions
Application ANDA201580
Marketing category ANDA
Marketing start 2012-05-18
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 2022-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A201580-001 TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201580-001 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 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201580-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2013-06-14 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4530-0 Tranexamic Acid 10 mL in 1 VIAL INJECTION, SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4530 TRANEXAMIC ACID INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] 4 Legacy NDC, 1 package rows 20210417_19f3483e-da9f-4a11-b2eb-b3c6d5d92fc8.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tranexamic Acid TRANEXAMIC ACID XGen Pharmaceuticals DJB, Inc. 1553f7eb-d5a8-4274-9762-5bcc5ffcf809 2025-11-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201580 application number: ANDA201580
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 50090-4530-0 50090453000 10 mL in 1 VIAL (50090-4530-0) 10 ml 2019-09-17 0000-00-00 No No Current