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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	68135-020		UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	68135-020	68135-020-99	UNFINISHED	Active or certified unfinished drug listing		2026-08-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	68135-020-99	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	68135-020-99	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	68135-020-99	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	68135-020-99	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	68135-020-99	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	68135-020-99	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	68135-020-99	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	68135-020-99	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	68135-020-99	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	68135-020-99	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	68135-020-99	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	68135-020-99	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	68135-020-99	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	68135-020-99	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	68135-020-99	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	68135-020-99	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	68135-020-99	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	68135-020-99	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	68135-020-99	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	68135-020-99	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	68135-020-99	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GALSULFASE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
59UA429E5G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
578037	Internal RxNorm lookup
584222	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
59341250-deac-ed71-3823-a4f5d64dbd77	Available on FDA.report

DailyMed Package Descriptions#

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

DailyMed Billing Units#

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

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

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

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
NAGLAZYME	GALSULFASE	BioMarin Pharmaceutical Inc.	59341250-deac-ed71-3823-a4f5d64dbd77	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125117 ndc (product): 68135-020

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125117	Naglazyme	galsulfase	351(a)	Rx	2026-07-01

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

DailyMed RxNorm Mappings#

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

Packages#

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
68135-020-99	68135002099	20000 mL in 1 BAG (68135-020-99)	20000 ml	09-JUN-05				Current