FDA.reportPublic FDA data

Palynziq

Product NDC
68135-058
11-digit product format
681350058
Labeler code
68135
Product ID
68135-058_b7b7caec-2808-4d88-ae34-1129a2cb1aef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegvaliase-pqpz
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
BioMarin Pharmaceutical Inc.
Application
BLA761079
Marketing category
BLA
Marketing start
2018-05-24
Substance
PEGVALIASE
Active strength
2.5 mg/.5mL
Pharmacologic classes
Phenylalanine Ammonia-Lyase [CS], Phenylalanine Metabolizing Enzyme [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Palynziq
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGVALIASE2.5 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N6UAH27EUVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2046365Internal RxNorm lookup
2046370Internal RxNorm lookup
2046374Internal RxNorm lookup
2046376Internal RxNorm lookup
2046379Internal RxNorm lookup
2046380Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6dba844a-db02-44f8-8593-ce497ed9406cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
11b26f26-d565-4782-b64a-ee0c8fe3b7d0Product name120180731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68135-058-89Palynziq0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.536
68135-058-90Palynziq1 in 1 CARTONINJECTION, SOLUTION136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68135-058-89ML - Milliliter68135-0587107df66-3c1b-472b-a159-c875285669f112019-08-06
68135-058-90ML - Milliliter68135-058376e4dfa-4593-4cf5-b579-0e7f1dd8d35712018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-058PALYNZIQ (PEGVALIASE-PQPZ) INJECTION, SOLUTION [BIOMARIN PHARMACEUTICAL INC.]33Current NDC, Legacy NDC, 2 package rows20221223_6dba844a-db02-44f8-8593-ce497ed9406c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PalynziqPEGVALIASE-PQPZBioMarin Pharmaceutical Inc.6dba844a-db02-44f8-8593-ce497ed9406c2026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761079
ndc (product): 68135-058

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761079Palynziqpegvaliase-pqpz351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2046370Palynziq 10 MG in 0.5 mL Prefilled SyringePSN6dba844a-db02-44f8-8593-ce497ed9406c36
2046376Palynziq 2.5 MG in 0.5 mL Prefilled SyringePSN6dba844a-db02-44f8-8593-ce497ed9406c36
2046380Palynziq 20 MG in 1 mL Prefilled SyringePSN6dba844a-db02-44f8-8593-ce497ed9406c36
2046365pegvaliase-pqpz 10 MG in 0.5 mL Prefilled SyringePSN6dba844a-db02-44f8-8593-ce497ed9406c36
2046374pegvaliase-pqpz 2.5 MG in 0.5 mL Prefilled SyringePSN6dba844a-db02-44f8-8593-ce497ed9406c36
2046379pegvaliase-pqpz 20 MG in 1 mL Prefilled SyringePSN6dba844a-db02-44f8-8593-ce497ed9406c36
20463700.5 ML pegvaliase-pqpz 20 MG/ML Prefilled Syringe [Palynziq]SBD6dba844a-db02-44f8-8593-ce497ed9406c36
20463760.5 ML pegvaliase-pqpz 5 MG/ML Prefilled Syringe [Palynziq]SBD6dba844a-db02-44f8-8593-ce497ed9406c36
20463801 ML pegvaliase-pqpz 20 MG/ML Prefilled Syringe [Palynziq]SBD6dba844a-db02-44f8-8593-ce497ed9406c36
20463650.5 ML pegvaliase-pqpz 20 MG/ML Prefilled SyringeSCD6dba844a-db02-44f8-8593-ce497ed9406c36
20463740.5 ML pegvaliase-pqpz 5 MG/ML Prefilled SyringeSCD6dba844a-db02-44f8-8593-ce497ed9406c36
20463791 ML pegvaliase-pqpz 20 MG/ML Prefilled SyringeSCD6dba844a-db02-44f8-8593-ce497ed9406c36
20463700.5 ML Palynziq 20 MG/ML Prefilled SyringeSY6dba844a-db02-44f8-8593-ce497ed9406c36
20463760.5 ML Palynziq 5 MG/ML Prefilled SyringeSY6dba844a-db02-44f8-8593-ce497ed9406c36
20463801 ML Palynziq 20 MG/ML Prefilled SyringeSY6dba844a-db02-44f8-8593-ce497ed9406c36
2046370Palynziq 10 MG per 0.5 ML Prefilled SyringeSY6dba844a-db02-44f8-8593-ce497ed9406c36
2046376Palynziq 2.5 MG per 0.5 ML Prefilled SyringeSY6dba844a-db02-44f8-8593-ce497ed9406c36
2046380Palynziq 20 MG per 1 ML Prefilled SyringeSY6dba844a-db02-44f8-8593-ce497ed9406c36
2046365pegvaliase-pqpz 10 MG per 0.5 ML Prefilled SyringeSY6dba844a-db02-44f8-8593-ce497ed9406c36
2046374pegvaliase-pqpz 2.5 MG per 0.5 ML Prefilled SyringeSY6dba844a-db02-44f8-8593-ce497ed9406c36
2046379pegvaliase-pqpz 20 MG per 1 ML Prefilled SyringeSY6dba844a-db02-44f8-8593-ce497ed9406c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68135-058-89681350058890.5 mL in 1 SYRINGE0.5 mlHistorical
68135-058-90681350058901 SYRINGE in 1 CARTON (68135-058-90) / .5 mL in 1 SYRINGE (68135-058-89) 1 syringe2018-05-240000-00-00NoNoCurrent