FDA.reportPublic FDA data

Rylaze

Product NDC
68727-900
11-digit product format
687270900
Labeler code
68727
Product ID
68727-900_cca29ff5-d000-43da-b64a-c65816a8a9c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
asparaginase erwinia chrysanthemi (recombinant)-rywn
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Jazz Pharmaceuticals, Inc.
Application
BLA761179
Marketing category
BLA
Marketing start
2021-06-30
Substance
ASPARAGINASE
Active strength
20 mg/mL
Pharmacologic classes
Asparaginase [CS], Asparagine-specific Enzyme [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rylaze
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPARAGINASE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G4FQ3CKY5RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2561251Internal RxNorm lookup
2561256Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
857e53aa-1098-4dad-b654-0276cdd43e03Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
ecb42c05-a297-4ddf-bbd1-f324912e7232Product name120220125
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68727-900-01Rylaze0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION0.57
68727-900-03Rylaze3 in 1 CARTONINJECTION37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68727-900-01ML - Milliliter68727-900bae545c0-eb51-4e5b-80b3-7f4684dc1c2712021-08-05
68727-900-03ML - Milliliter68727-900f9e8a75a-28d1-4d27-9105-b693d1911f0512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68727-900RYLAZE (ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN) INJECTION [JAZZ PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20241010_857e53aa-1098-4dad-b654-0276cdd43e03.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
RylazeASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWNJazz Pharmaceuticals, Inc.857e53aa-1098-4dad-b654-0276cdd43e032025-07-01Warnings, Adverse reactionsExact identifier
application number: BLA761179
ndc (product): 68727-900

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761179Rylazeasparaginase erwinia chrysanthemi (recombinant)-rywn351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2561251asparaginase Erwinia chrysanthemi (recombinant)-rywn 10 MG in 0.5 ML InjectionPSN857e53aa-1098-4dad-b654-0276cdd43e037
2561256RYLAZE 10 MG in 0.5 ML InjectionPSN857e53aa-1098-4dad-b654-0276cdd43e037
25612560.5 ML asparaginase Erwinia chrysanthemi (recombinant)-rywn 20 MG/ML Injection [Rylaze]SBD857e53aa-1098-4dad-b654-0276cdd43e037
25612510.5 ML asparaginase Erwinia chrysanthemi (recombinant)-rywn 20 MG/ML InjectionSCD857e53aa-1098-4dad-b654-0276cdd43e037
25612560.5 ML Rylaze 20 MG/ML InjectionSY857e53aa-1098-4dad-b654-0276cdd43e037
2561251asparaginase Erwinia chrysanthemi (recombinant)-rywn 10 MG per 0.5 ML InjectionSY857e53aa-1098-4dad-b654-0276cdd43e037
2561256Rylaze 10 MG per 0.5 ML InjectionSY857e53aa-1098-4dad-b654-0276cdd43e037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68727-900-01687270900010.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical
68727-900-03687270900033 VIAL, SINGLE-DOSE in 1 CARTON (68727-900-03) / .5 mL in 1 VIAL, SINGLE-DOSE (68727-900-01) 2021-06-300000-00-00NoNoCurrent