Tranexamic Acid

Product NDC: 39822-1000
11-digit product format: 398221000
Labeler code: 39822
Product ID: 39822-1000_41c0f4cf-abe1-fec5-e063-6294a90a9b91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tranexamic Acid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: XGen Pharmaceuticals DJB, Inc.
Application: ANDA201580
Marketing category: ANDA
Marketing start: 2012-05-18
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

Additional Listing Data#

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

Field, Values table
Field	Values
Unii	6T84R30KC1
Rxcui	238720

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
39822-1000-1	Tranexamic Acid	10 mL in 1 VIAL	INJECTION, SOLUTION	10		10
39822-1000-1	Tranexamic Acid	10 in 1 CARTON	INJECTION, SOLUTION	10		10

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
39822-1000-1	ML - Milliliter	39822-1000	894becc6-ee1c-4bab-882d-a94c33a1a55a	1	2013-09-04

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRANEXAMIC ACID	ACTIVE INGREDIENT	6T84R30KC1	TRANEXAMIC ACID INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.]	2
TRANEXAMIC ACID	ACTIVE MOIETY	6T84R30KC1	TRANEXAMIC ACID INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRANEXAMIC ACID INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
39822-1000	TRANEXAMIC ACID INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20241208_1553f7eb-d5a8-4274-9762-5bcc5ffcf809.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6T84R30KC1	TRANEXAMIC ACID	1197-18-8	TRANEXAMIC ACID

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238720	tranexamic acid 1000 MG in 10 ML Injection	PSN	1553f7eb-d5a8-4274-9762-5bcc5ffcf809	10
238720	10 ML tranexamic acid 100 MG/ML Injection	SCD	1553f7eb-d5a8-4274-9762-5bcc5ffcf809	10
238720	tranexamic acid 1000 MG per 10 ML Injection	SY	1553f7eb-d5a8-4274-9762-5bcc5ffcf809	10
238720	tranexamic acid 1000 MG in 10 ML Injection	PSN	19f3483e-da9f-4a11-b2eb-b3c6d5d92fc8	4
238720	10 ML tranexamic acid 100 MG/ML Injection	SCD	19f3483e-da9f-4a11-b2eb-b3c6d5d92fc8	4
238720	tranexamic acid 1000 MG per 10 ML Injection	SY	19f3483e-da9f-4a11-b2eb-b3c6d5d92fc8	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
39822-1000-1	39822100001	10 VIAL in 1 CARTON (39822-1000-1) / 10 mL in 1 VIAL	10 vial	2012-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tranexamic Acid	XGen Pharmaceuticals DJB, Inc.	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	10
Tranexamic Acid	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	4