Tranexamic acid

Product NDC: 68083-160
Requested package NDC: 68083-160-10
11-digit product format: 680830160
Labeler code: 68083
Product ID: 68083-160_774f8480-57d6-4085-a0b8-636d3b79c8c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tranexamic acid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA207239
Marketing category: ANDA
Marketing start: 2017-02-22
Substance: TRANEXAMIC ACID
Active strength: 100 mg/mL
Pharmacologic classes: Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: Tranexamic acid
Listing expiration: 2027-12-31

Active Ingredients#

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

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	Strength	SPL version
68083-160-10	Tranexamic acid	10 mL in 1 VIAL	INJECTION, SOLUTION	10		9
68083-160-10	Tranexamic acid	10 in 1 CARTON	INJECTION, SOLUTION	10		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-160	TRANEXAMIC ACID INJECTION, SOLUTION [GLAND PHARMA LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20210630_31462875-4941-4d50-bf0c-9675493731f3.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	31462875-4941-4d50-bf0c-9675493731f3	9
238720	10 ML tranexamic acid 100 MG/ML Injection	SCD	31462875-4941-4d50-bf0c-9675493731f3	9
238720	tranexamic acid 1000 MG per 10 ML Injection	SY	31462875-4941-4d50-bf0c-9675493731f3	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-160-10	68083016010	10 VIAL in 1 CARTON (68083-160-10) / 10 mL in 1 VIAL	10 vial	2017-02-22	0000-00-00	No	No	Current