Tranexamic Acid

Manufacturer: Emcure Pharmaceuticals Limited
Effective date: 2024-10-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:15:57

Label at a glance#

ProductTranexamic Acid

Active ingredientTRANEXAMIC ACID

Label structure2 sections

Indications and uses

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 14593-318-01

Tranexamic Acid Injection, USP

1000 mg/10 mL

(100 mg/mL)

Intravenous Use Only

Rx only

10 mL Single-Dose Vial

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238720	tranexamic acid 1000 MG in 10 ML Injection	PSN	1
238720	10 ML tranexamic acid 100 MG/ML Injection	SCD	1
238720	tranexamic acid 1000 MG per 10 ML Injection	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TRANEXAMIC ACID Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8234c772-5c41-424c-a33e-e06e8c4de9c1	Product name	2	20250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923b	Product name	4	20250224
510b43a3-8143-a25f-19c6-476c90dbb618	Product name	9	20171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
14593-318-01	Tranexamic Acid	10 in 1 CARTON	INJECTION, SOLUTION	10		1
14593-318-01	Tranexamic Acid	10 mL in 1 VIAL	INJECTION, SOLUTION	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14593-318	TRANEXAMIC ACID INJECTION, SOLUTION [EMCURE PHARMACEUTICALS LIMITED]	1	Current NDC, 2 package rows	20241030_ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Tranexamic Acid
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
14593-318	14593-318-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TRANEXAMIC ACID	6T84R30KC1	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A203521-001	TRANEXAMIC ACID	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP		2014-08-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A203521-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203521-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203521-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203521-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203521-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203521-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203521-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203521-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203521-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203521-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203521-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203521-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203521-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203521-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203521-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203521-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203521-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203521-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203521-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203521-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203521-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203521-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203521-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203521-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203521-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203521-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203521-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203521-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203521-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203521-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203521-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203521-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203521-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203521-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203521-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203521-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203521-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203521-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203521-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203521-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203521-001	AP	1	`f41ea6bd6efb…`

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	Emcure Pharmaceuticals Limited	ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a	2024-10-28		Exact identifier ndc (package): 14593-318-01 ndc (product): 14593-318 ndc11 (package): 14593031801 spl id: 996040a7-8eaa-4dcc-ba36-5c37d4db8113 spl set id: ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.