tranexamic acid

Product NDC: 83634-401
11-digit product format: 836340401
Labeler code: 83634
Product ID: 83634-401_5dece4b5-d95e-4fe7-b0ed-89bd573f2fad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tranexamic acid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Avenacy, Inc.
Application: ANDA203521
Marketing category: ANDA
Marketing start: 2024-06-01
Substance: TRANEXAMIC ACID
Active strength: 100 mg/mL
Pharmacologic classes: Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A203521-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203521-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: tranexamic acid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRANEXAMIC ACID	100 mg/mL

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
238720	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
00630e54-0e84-465d-96a5-63486c87dcd9	Available on FDA.report

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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
83634-401-10	tranexamic acid	10 in 1 CARTON	INJECTION, SOLUTION	10		1
83634-401-41	tranexamic acid	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83634-401-10	ML - Milliliter	83634-401	70867fb0-73d8-43e3-8654-eb23eea82d49	1	2024-07-12
83634-401-41	ML - Milliliter	83634-401	e856703d-1fa1-40bf-99f6-ae4efdd7268d	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83634-401	TRANEXAMIC ACID INJECTION, SOLUTION [AVENACY, INC.]	1	Current NDC, 2 package rows	20240601_00630e54-0e84-465d-96a5-63486c87dcd9.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tranexamic Acid	TRANEXAMIC ACID	Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	28ccedba-99cd-49f3-a782-798df5258524	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203521 application number: ANDA203521
Tranexamic Acid	TRANEXAMIC ACID	Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	d5f55a98-aeb8-47e1-9154-87ba70222027	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203521 application number: ANDA203521
TRANEXAMIC ACID	TRANEXAMIC ACID	Northstar Rx LLC	faa7c6bc-d7b9-48d5-9446-542a6a376db8	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203521 application number: ANDA203521
Tranexamic Acid	TRANEXAMIC ACID	Emcure Pharmaceuticals Limited	ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a	2024-10-28		Exact identifier application applno (ANDA): 203521 application number: ANDA203521
tranexamic acid	TRANEXAMIC ACID	Avenacy, Inc.	00630e54-0e84-465d-96a5-63486c87dcd9	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203521 application number: ANDA203521 ndc (product): 83634-401

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6T84R30KC1	TRANEXAMIC ACID	1197-18-8	TRANEXAMIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238720	tranexamic acid 1000 MG in 10 ML Injection	PSN	00630e54-0e84-465d-96a5-63486c87dcd9	1
238720	10 ML tranexamic acid 100 MG/ML Injection	SCD	00630e54-0e84-465d-96a5-63486c87dcd9	1
238720	tranexamic acid 1000 MG per 10 ML Injection	SY	00630e54-0e84-465d-96a5-63486c87dcd9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83634-401-10	83634040110	10 VIAL, SINGLE-DOSE in 1 CARTON (83634-401-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-401-41)		2024-06-01	No	No	Current
83634-401-41	83634040141	10 mL in 1 VIAL, SINGLE-DOSE	10 ml				Historical