Tranexamic Acid

Product NDC: 67850-042
11-digit product format: 678500042
Labeler code: 67850
Product ID: 67850-042_f94b3514-bcf9-4bfc-bcb9-5d104e874cca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tranexamic Acid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Methapharm, Inc.
Application: ANDA202436
Marketing category: ANDA
Marketing start: 2019-03-11
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67850-042		D	Discontinued by firm		2026-08-07
excluded package	package	67850-042	67850-042-10	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202436-001	TRANEXAMIC ACID	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP		2014-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202436-001	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
2026-02-19 14:30 UTC	2026-02	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202436-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-02-11	`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
2026-02-19 14:30 UTC	2026-02	A202436-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202436-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202436-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202436-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202436-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202436-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202436-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202436-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202436-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202436-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202436-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202436-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202436-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202436-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202436-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202436-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202436-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202436-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202436-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202436-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202436-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202436-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202436-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202436-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202436-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202436-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202436-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202436-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202436-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202436-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202436-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202436-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202436-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202436-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202436-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202436-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202436-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202436-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202436-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202436-001	AP	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67850-042-00	ML - Milliliter	67850-042	bd1a0a1a-03ca-48b7-af4f-ec80e9718a2a	1	2020-02-13
67850-042-10	ML - Milliliter	67850-042	295d21c5-4e9f-4841-9abd-b14647dbce47	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67850-042	TRANEXAMIC ACID INJECTION, SOLUTION [METHAPHARM, INC.]	11	Legacy NDC	20241208_3bb850aa-2061-4c30-848a-82871ff7bbf5.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	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	4f42a81c-37e3-4b57-8e9a-d42c55bbfc52	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202436 application number: ANDA202436

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
67850-042-10	67850004210	10 AMPULE in 1 CARTON (67850-042-10) > 10 mL in 1 AMPULE (67850-042-00)	10 ampule	2019-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tranexamic Acid	Methapharm, Inc. \| ACIC Pharmaceuticals Inc. \| Bioindustria Laboratorio Italiano Medicinali S.p.A.	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	12
Tranexamic Acid Injection	Methapharm, Inc.	2019-11-06	HUMAN PRESCRIPTION DRUG LABEL	3