What is NDC 68135-811?

68135-811 is the product NDC for Brineura (cerliponase alfa) kit, 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 Brineura?

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.

Brineura NDC 68135-811 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68135-811Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68135-0811Add 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
68135-811-02	68135081102	1 KIT in 1 CARTON (68135-811-02) * 5 mL in 1 VIAL, GLASS (68135-500-00) * 5 mL in 1 VIAL, GLASS (68135-495-04)Marketed from Apr 27, 2017

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): Brineura
Generic name (nonproprietary): cerliponase alfa
Dosage form: Kit
Labeler: BioMarin Pharmaceutical Inc.NDC labeler code 68135
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761052
Marketing start: Apr 27, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 68135-811_1ebeb049-90ec-42ff-9361-b6fa38d79515SPL ID 1ebeb049-90ec-42ff-9361-b6fa38d79515SPL set ID 485ab3c5-0359-4878-872f-2fe1e7df4047RxCUI 1922453, 1922458

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.

NDC on a medical claim

N468135081102 followed by a unit qualifier and the quantity

Package 68135-0811-02. 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 Aug 5, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

BRINEURA is indicated to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. BRINEURA is a hydrolytic lysosomal N-terminal tripeptidyl peptidase indicated to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68135-811

What is NDC 68135-811?: 68135-811 is the product NDC for Brineura (cerliponase alfa) kit, 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?: Brineura (Cerliponase alfa).
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 Brineura?: 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.

Brineura (Cerliponase alfa) NDC 68135-811