NDC 68135-673-39 - Palynziq

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68135-673
Requested NDC: 68135-673-39
Package NDCs from labels: 68135-673-39, 68135-673-40, 68135-673-45
Manufacturer: BioMarin Pharmaceutical Inc.
Effective date: 2026-03-02
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Palynziq - BioMarin Pharmaceutical Inc.	BioMarin Pharmaceutical Inc.	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68135-673-39	Palynziq	1 mL in 1 SYRINGE	INJECTION, SOLUTION	1	36
68135-673-40	Palynziq	1 in 1 CARTON	INJECTION, SOLUTION	1	36
68135-673-45	Palynziq	10 in 1 CARTON	INJECTION, SOLUTION	10	36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68135-673	PALYNZIQ (PEGVALIASE-PQPZ) INJECTION, SOLUTION [BIOMARIN PHARMACEUTICAL INC.]	33	Current NDC, Legacy NDC, 3 package rows	20221223_6dba844a-db02-44f8-8593-ce497ed9406c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68135-673-39	ML - Milliliter	68135-673	090cae82-2051-49cc-84a0-c5038d7bd15e	1	2019-08-06
68135-673-40	ML - Milliliter	68135-673	34cb317b-119b-47e0-ba41-b6ca093ceb7d	1	2018-06-11
68135-673-45	ML - Milliliter	68135-673	71a84406-339a-431a-9857-b6a3ba576850	1	2018-06-11

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
Palynziq	PEGVALIASE-PQPZ	BioMarin Pharmaceutical Inc.	6dba844a-db02-44f8-8593-ce497ed9406c	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761079 ndc (package): 68135-673-40 ndc (package): 68135-756-19 ndc (package): 68135-673-39 ndc (package): 68135-756-20 ndc (package): 68135-058-89 ndc (package): 68135-673-45 ndc (package): 68135-058-90 ndc (product): 68135-756 ndc (product): 68135-673 ndc (product): 68135-058 ndc11 (package): 68135067339 rxcui: 2046380 rxcui: 2046379 rxcui: 2046376 rxcui: 2046374 rxcui: 2046365 rxcui: 2046370 spl id: b7b7caec-2808-4d88-ae34-1129a2cb1aef spl set id: 6dba844a-db02-44f8-8593-ce497ed9406c unii: N6UAH27EUV

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.