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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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	2026-06-01

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