ALDURAZYME

Product NDC: 58468-0070
11-digit product format: 584680070
Labeler code: 58468
Product ID: 58468-0070_a6819483-3275-4b44-8e87-f6246503af43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: laronidase
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Genzyme Corporation
Application: BLA125058
Marketing category: BLA
Marketing start: 2003-04-30
Substance: LARONIDASE
Active strength: 2.9 mg/5mL
Pharmacologic classes: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC], alpha-Glucosidases [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
LARONIDASE	2.9 mg/5mL

Field, Values table
Field	Values
Unii	WP58SVM6R4
Rxcui	403822, 404492

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58468-0070-1	ALDURAZYME	5 mL in 1 VIAL, GLASS	INJECTION, SOLUTION, CONCENTRATE	5		37

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58468-0070-1	ML - Milliliter	58468-0070	badfca37-3948-4cd6-a8de-04dfd0679aab	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LARONIDASE	ACTIVE INGREDIENT	WP58SVM6R4	ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION]	11
LARONIDASE	ACTIVE MOIETY	WP58SVM6R4	ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION]	11
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION]	11
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION]	11
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INACTIVE INGREDIENT	70WT22SF4B	ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION]	11
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION]	11

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58468-0070	ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION]	36	Current NDC, Legacy NDC, 1 package rows	20241010_a80ac249-cae4-41f3-88bb-344088b20e60.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WP58SVM6R4	LARONIDASE	210589-09-6	LARONIDASE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
404492	ALDURAZYME 2.9 MG in 5 ML Injection	PSN	a80ac249-cae4-41f3-88bb-344088b20e60	37
403822	laronidase 2.9 MG in 5 ML Injection	PSN	a80ac249-cae4-41f3-88bb-344088b20e60	37
404492	5 ML laronidase 0.58 MG/ML Injection [Aldurazyme]	SBD	a80ac249-cae4-41f3-88bb-344088b20e60	37
403822	5 ML laronidase 0.58 MG/ML Injection	SCD	a80ac249-cae4-41f3-88bb-344088b20e60	37
404492	5 ML Aldurazyme 0.58 MG/ML Injection	SY	a80ac249-cae4-41f3-88bb-344088b20e60	37
404492	Aldurazyme 2.9 MG per 5 ML Injection	SY	a80ac249-cae4-41f3-88bb-344088b20e60	37
403822	laronidase 2.9 MG per 5 ML Injection	SY	a80ac249-cae4-41f3-88bb-344088b20e60	37

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58468-0070-1	58468007001	5 mL in 1 VIAL, GLASS (58468-0070-1)	5 ml	2003-04-30	0000-00-00	No	No	Current