What is NDC 68135-020?

68135-020 is the product NDC for Naglazyme (galsulfase), Galsulfase 5 mg/5mL solution, listed with the FDA by BioMarin Pharmaceutical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

BioMarin Pharmaceutical Inc., NDC labeler code 68135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Naglazyme?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Naglazyme NDC 68135-020 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68135-020Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68135-0020Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68135-020-01	68135002001	1 VIAL in 1 CARTON (68135-020-01) / 5 mL in 1 VIALMarketed from Jun 9, 2005

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Naglazyme
Generic name (nonproprietary): galsulfase
Active ingredients: Galsulfase — 5 mg/5mL
Dosage form: Solution
Route: Intravenous
Labeler: BioMarin Pharmaceutical Inc.NDC labeler code 68135
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125117
Marketing start: Jun 9, 2005
Listing expires: Dec 31, 2026
Other FDA classes: alpha-Glucosidases (Chemical structure)
Identifiers: Product ID 68135-020_02482a8a-8333-4e9c-a9dc-ff7780f40363SPL ID 02482a8a-8333-4e9c-a9dc-ff7780f40363SPL set ID 59341250-deac-ed71-3823-a4f5d64dbd77RxCUI 578037, 584222UNII 59UA429E5G
Pharmacologic class: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468135002001 followed by a unit qualifier and the quantity

Package 68135-0020-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 18, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

NAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. NAGLAZYME is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68135-020

What is NDC 68135-020?: 68135-020 is the product NDC for Naglazyme (galsulfase), Galsulfase 5 mg/5mL solution, listed with the FDA by BioMarin Pharmaceutical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Naglazyme (Galsulfase).
What is the active ingredient?: Galsulfase.
Who is the labeler?: BioMarin Pharmaceutical Inc., NDC labeler code 68135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naglazyme?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Naglazyme (Galsulfase) NDC 68135-020