FDA.reportPublic FDA data

Palynziq

Product NDC
68135-673
11-digit product format
681350673
Labeler code
68135
Product ID
68135-673_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
20 mg/mL
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
PEGVALIASE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN6UAH27EUV
Rxcui2046365, 2046370, 2046374, 2046376, 2046379, 2046380

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
68135-673-39Palynziq1 mL in 1 SYRINGEINJECTION, SOLUTION136
68135-673-40Palynziq1 in 1 CARTONINJECTION, SOLUTION136
68135-673-45Palynziq10 in 1 CARTONINJECTION, SOLUTION1036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68135-673-39ML - Milliliter68135-673090cae82-2051-49cc-84a0-c5038d7bd15e12019-08-06
68135-673-40ML - Milliliter68135-67334cb317b-119b-47e0-ba41-b6ca093ceb7d12018-06-11
68135-673-45ML - Milliliter68135-67371a84406-339a-431a-9857-b6a3ba57685012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-673PALYNZIQ (PEGVALIASE-PQPZ) INJECTION, SOLUTION [BIOMARIN PHARMACEUTICAL INC.]33Current NDC, Legacy NDC, 3 package rows20221223_6dba844a-db02-44f8-8593-ce497ed9406c.zip

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
68135-673-39681350673391 mL in 1 SYRINGE1 mlHistorical
68135-673-40681350673401 SYRINGE in 1 CARTON (68135-673-40) / 1 mL in 1 SYRINGE (68135-673-39) 1 syringe2018-05-240000-00-00NoNoCurrent
68135-673-456813506734510 SYRINGE in 1 CARTON (68135-673-45) / 1 mL in 1 SYRINGE (68135-673-39) 10 syringe2018-05-240000-00-00NoNoCurrent