NAGLAZYME

Product NDC: 68135-020
11-digit product format: 681350020
Labeler code: 68135
Product ID: 68135-020_02482a8a-8333-4e9c-a9dc-ff7780f40363
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: galsulfase
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: BioMarin Pharmaceutical Inc.
Application: BLA125117
Marketing category: BLA
Marketing start: 2005-06-09
Substance: GALSULFASE
Active strength: 5 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
GALSULFASE	5 mg/5mL

Field, Values table
Field	Values
Unii	59UA429E5G
Rxcui	578037, 584222

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68135-020-01	NAGLAZYME	1 in 1 CARTON	SOLUTION	1		39
68135-020-01	NAGLAZYME	5 mL in 1 VIAL	SOLUTION	5		39

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68135-020-01	ML - Milliliter	68135-020	803746f2-88ac-4faf-81b3-567008612807	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GALSULFASE	ACTIVE INGREDIENT	59UA429E5G	NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.]	10
GALSULFASE	ACTIVE MOIETY	59UA429E5G	NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.]	10
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.]	10
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INACTIVE INGREDIENT	70WT22SF4B	NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.]	10
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.]	10

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68135-020	NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.]	39	Current NDC, Legacy NDC, 2 package rows	20241212_59341250-deac-ed71-3823-a4f5d64dbd77.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
59UA429E5G	GALSULFASE	552858-79-4	GALSULFASE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
578037	galsulfase 5 MG in 5 ML Injection	PSN	59341250-deac-ed71-3823-a4f5d64dbd77	39
584222	Naglazyme 5 MG in 5 ML Injection	PSN	59341250-deac-ed71-3823-a4f5d64dbd77	39
584222	5 ML galsulfase 1 MG/ML Injection [Naglazyme]	SBD	59341250-deac-ed71-3823-a4f5d64dbd77	39
578037	5 ML galsulfase 1 MG/ML Injection	SCD	59341250-deac-ed71-3823-a4f5d64dbd77	39
584222	5 ML Naglazyme 1 MG/ML Injection	SY	59341250-deac-ed71-3823-a4f5d64dbd77	39
578037	galsulfase 5 MG per 5 ML Injection	SY	59341250-deac-ed71-3823-a4f5d64dbd77	39
584222	Naglazyme 5 MG per 5 ML Injection	SY	59341250-deac-ed71-3823-a4f5d64dbd77	39

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68135-020-01	68135002001	1 VIAL in 1 CARTON (68135-020-01) / 5 mL in 1 VIAL	1 vial	2005-06-09	0000-00-00	No	No	Current