tranexamic acid

Product NDC: 50090-5072
11-digit product format: 500905072
Labeler code: 50090
Product ID: 50090-5072_6e62d43c-fb21-41db-9384-827b9e253aa0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tranexamic Acid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: A-S Medication Solutions
Application: ANDA212676
Marketing category: ANDA
Marketing start: 2019-09-30
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	50090-5072		D	Discontinued by firm		2026-08-17
excluded package	package	50090-5072	50090-5072-0	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 · 4 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	50090-5072-0	`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	50090-5072-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A212676-001	TRANEXAMIC ACID	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP		2019-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212676-001	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
2026-08-18 06:07:40	2026-07	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212676-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`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
2026-08-18 06:07:40	2026-07	A212676-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212676-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212676-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212676-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212676-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212676-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212676-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212676-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212676-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212676-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212676-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212676-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212676-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212676-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212676-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212676-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212676-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212676-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212676-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212676-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212676-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212676-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212676-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212676-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212676-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212676-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212676-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212676-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212676-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212676-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212676-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212676-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212676-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212676-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212676-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212676-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212676-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212676-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212676-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212676-001	AP	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5072-0	2023-02-07	C162847	48780-1	f386c649-a6c0-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safetly and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986
50090-5072-0	2023-01-30	C162847	48780-1	f386c649-a6c0-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safetly and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5072	TRANEXAMIC ACID INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]	5	Legacy NDC	20230208_8004da00-e3d1-4a77-88ec-ccbde822a803.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	Provepharm Inc.	1b8c3500-8e87-4b6e-b6a9-8da5f9c00820	2025-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212676 application number: ANDA212676

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
50090-5072-0	50090507200	10 mL in 1 VIAL, SINGLE-DOSE (50090-5072-0)	10 ml	2020-06-08	0000-00-00	No	No	Current