Tranexamic Acid

Product NDC: 0517-0960
11-digit product format: 005170960
Labeler code: 0517
Product ID: 0517-0960_1a8db732-66d1-443c-9664-08f9e84903f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tranexamic acid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: American Regent, Inc.
Application: ANDA201885
Marketing category: ANDA
Marketing start: 2011-11-15
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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0517-0960		D	Discontinued by firm	2026-08-17
excluded package	package	0517-0960	0517-0960-01	D	Discontinued by firm	2026-08-17
excluded package	package	0517-0960	0517-0960-10	D	Discontinued by firm	2026-08-17

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
A201885-001	TRANEXAMIC ACID	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP		2011-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201885-001	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	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201885-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2011-08-10	`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	A201885-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201885-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201885-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201885-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201885-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201885-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201885-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201885-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201885-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201885-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201885-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201885-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201885-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201885-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201885-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201885-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201885-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201885-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201885-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201885-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201885-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201885-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201885-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201885-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201885-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201885-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201885-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201885-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201885-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201885-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201885-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201885-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201885-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201885-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201885-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201885-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201885-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201885-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201885-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201885-001	AP	1	`e64feba35796…`

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	SPL version
0517-0960-01	Tranexamic Acid	1 in 1 CARTON	INJECTION, SOLUTION	1	19
0517-0960-01	Tranexamic Acid	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	10	19
0517-0960-10	Tranexamic Acid	10 in 1 CARTON	INJECTION, SOLUTION	10	19
0517-0960-10	Tranexamic Acid	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	10	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-0960-01	ML - Milliliter	0517-0960	3b09c4e1-cdfb-4a40-a063-6d1f7db5aaef	1	2015-06-09
0517-0960-10	ML - Milliliter	0517-0960	7f3a7060-d0b5-4d0b-bc13-2ae1d5da8169	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRANEXAMIC ACID	ACTIVE INGREDIENT	6T84R30KC1	TRANEXAMIC ACID INJECTION, SOLUTION [AMERICAN REGENT, INC.]	7
TRANEXAMIC ACID	ACTIVE MOIETY	6T84R30KC1	TRANEXAMIC ACID INJECTION, SOLUTION [AMERICAN REGENT, INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRANEXAMIC ACID INJECTION, SOLUTION [AMERICAN REGENT, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-0960	TRANEXAMIC ACID INJECTION, SOLUTION [AMERICAN REGENT, INC.]	19	Current NDC, Legacy NDC, 4 package rows	20210501_81916afc-f83a-4bba-a810-17393980e27e.zip

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	81916afc-f83a-4bba-a810-17393980e27e	19
238720	10 ML tranexamic acid 100 MG/ML Injection	SCD	81916afc-f83a-4bba-a810-17393980e27e	19
238720	tranexamic acid 1000 MG per 10 ML Injection	SY	81916afc-f83a-4bba-a810-17393980e27e	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-0960-01	00517096001	1 VIAL, GLASS in 1 CARTON (0517-0960-01) / 10 mL in 1 VIAL, GLASS	2011-11-15	0000-00-00	No	No	Current
0517-0960-10	00517096010	10 VIAL, GLASS in 1 CARTON (0517-0960-10) / 10 mL in 1 VIAL, GLASS	2011-11-15	0000-00-00	No	No	Current