Tranexamic Acid

Product NDC: 70860-400
11-digit product format: 708600400
Labeler code: 70860
Product ID: 70860-400_965bbf85-2808-4653-9f61-649d9667b52c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tranexamic acid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA207239
Marketing category: ANDA
Marketing start: 2017-03-27
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70860-400		D	Discontinued by firm		2026-10-23
excluded package	package	70860-400	70860-400-10	D	Discontinued by firm		2026-10-23

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 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70860-400-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70860-400-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70860-400-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70860-400-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70860-400-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70860-400-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70860-400-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70860-400-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70860-400-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70860-400-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70860-400-10	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 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
2026-10-15 13:18:30	2026-09	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207239-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207239-001	AP	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70860-400-10	2024-03-05	C162847	48780-1	1030e365-4043-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986
70860-400-10	2024-01-30	C162847	48780-1	1030e365-4043-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-400-10	ML - Milliliter	70860-400	3e95a358-45dc-4bb5-a71a-a1d0a42f496a	1	2017-07-07
70860-400-41	ML - Milliliter	70860-400	a003debf-ac71-4135-9c56-787cd1028c42	1	2019-04-11

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-400-10	70860040010	10 VIAL in 1 CARTON (70860-400-10) > 10 mL in 1 VIAL (70860-400-41)	10 vial	2017-03-27	0000-00-00	No	No	Current