ANDEMBRY

Product NDC: 63833-925
11-digit product format: 638330925
Labeler code: 63833
Product ID: 63833-925_a15c0e04-117a-434d-8b34-b664701b787f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Garadacimab
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: CSL
Application: BLA761367
Marketing category: BLA
Marketing start: 2025-06-16
Substance: GARADACIMAB
Active strength: 200 mg/1.2mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: ANDEMBRY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GARADACIMAB	200 mg/1.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
32W6AJL0DY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2717175	Internal RxNorm lookup
2717182	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
07b0b671-db81-49f0-a402-0c0219db7fa2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63833-925-01	ANDEMBRY	1 in 1 CARTON	INJECTION, SOLUTION	1		5
63833-925-20	ANDEMBRY	1.2 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	1.2		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63833-925-01	ML - Milliliter	63833-925	74e0dbd7-792a-4744-86ab-2893c2a3befd	1	2025-07-08
63833-925-20	ML - Milliliter	63833-925	cb4a2885-d34f-4fa1-8ab3-fbb712e20b27	1	2025-07-08

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
ANDEMBRY	GARADACIMAB	CSL	07b0b671-db81-49f0-a402-0c0219db7fa2	2025-06-30	Warnings, Adverse reactions	Exact identifier application number: BLA761367 ndc (product): 63833-925

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761367	Andembry	garadacimab-gxii	351(a)	Rx	2026-08-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
32W6AJL0DY	GARADACIMAB	2162134-62-3	GARADACIMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2717182	ANDEMBRY 200 MG in 1.2 ML Auto-Injector	PSN	07b0b671-db81-49f0-a402-0c0219db7fa2	5
2717175	garadacimab-gxii 200 MG in 1.2 ML Auto-Injector	PSN	07b0b671-db81-49f0-a402-0c0219db7fa2	5
2717182	1.2 ML garadacimab-gxii 167 MG/ML Auto-Injector [Andembry]	SBD	07b0b671-db81-49f0-a402-0c0219db7fa2	5
2717175	1.2 ML garadacimab-gxii 167 MG/ML Auto-Injector	SCD	07b0b671-db81-49f0-a402-0c0219db7fa2	5
2717182	Andembry 200 MG per 1.2 ML Auto-Injector	SY	07b0b671-db81-49f0-a402-0c0219db7fa2	5
2717175	garadacimab-gxii 200 MG per 1.2 ML Auto-Injector	SY	07b0b671-db81-49f0-a402-0c0219db7fa2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63833-925-01	63833092501	1 SYRINGE, GLASS in 1 CARTON (63833-925-01) / 1.2 mL in 1 SYRINGE, GLASS (63833-925-20)		2025-06-16	No	No	Current
63833-925-20	63833092520	1.2 mL in 1 SYRINGE, GLASS	1.2 ml				Historical