Tranexamic Acid

Product NDC: 72611-760
Requested package NDC: 72611-760-10
11-digit product format: 726110760
Labeler code: 72611
Product ID: 72611-760_dcdf3a21-e589-e641-5a56-afbf0a6e738a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tranexamic acid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Almaject, Inc.
Application: ANDA207239
Marketing category: ANDA
Marketing start: 2021-03-01
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72611-760	72611-760-10	D	Discontinued by firm		2026-08-17

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 · 10 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…`

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
A207239-001	TRANEXAMIC ACID	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP		2017-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207239-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207239-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207239-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207239-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207239-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207239-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207239-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207239-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207239-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207239-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207239-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207239-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207239-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207239-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207239-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207239-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207239-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207239-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207239-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207239-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207239-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207239-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207239-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207239-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207239-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207239-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207239-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207239-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207239-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207239-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207239-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207239-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207239-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207239-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207239-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207239-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207239-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207239-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207239-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207239-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207239-001	AP	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72611-760-01	ML - Milliliter	72611-760	ca14f816-8ece-4fb8-9d9f-fbda4688557d	1	2021-11-09
72611-760-10	ML - Milliliter	72611-760	7abb5bc9-ff93-4f6d-a0a1-a9e5de9353fd	1	2021-11-09

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tranexamic acid	TRANEXAMIC ACID	Gland Pharma Limited	31462875-4941-4d50-bf0c-9675493731f3	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207239 application number: ANDA207239
Tranexamic Acid	TRANEXAMIC ACID	Sagent Pharmaceuticals	b28a18a4-391d-48ab-8fa5-6391f15553f3	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207239 application number: ANDA207239
Tranexamic Acid	TRANEXAMIC ACID	Sagent Pharmaceuticals	0277db2d-7c81-4cd0-ac19-fa12b5721428	2023-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207239 application number: ANDA207239

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72611-760-10	72611076010	10 VIAL, SINGLE-DOSE in 1 CARTON (72611-760-10) > 10 mL in 1 VIAL, SINGLE-DOSE (72611-760-01)	2021-03-01	0000-00-00	No	No	Current