FDA.reportPublic FDA data

Piasky

Product NDC
50242-115
11-digit product format
502420115
Labeler code
50242
Product ID
50242-115_04e8fab1-279a-466a-a2cf-52a0f9e550bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Crovalimab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA761388
Marketing category
BLA
Marketing start
2024-06-20
Substance
CROVALIMAB
Active strength
340 mg/2mL
Pharmacologic classes
Complement C5 Inhibitor [EPC], Complement C5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CROVALIMAB340 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H9KH1GP3UUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2686626Internal RxNorm lookup
2686633Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2597efc2-a97b-487c-b500-a67fd282a73bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
09d1cb41-6c3b-4e5a-80ca-8e1555f33038Product name120250226
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-115-01Piasky2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION23
50242-115-01Piasky1 in 1 CARTONINJECTION, SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-115-01ML - Milliliter50242-1155bd138fc-15b6-414c-a11d-fc237efc6fa912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-115PIASKY (CROVALIMAB) INJECTION, SOLUTION [GENENTECH, INC.]1Current NDC, 2 package rows20240704_2597efc2-a97b-487c-b500-a67fd282a73b.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
PiaskyCROVALIMABGenentech, Inc.2597efc2-a97b-487c-b500-a67fd282a73b2025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761388
ndc (product): 50242-115

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761388Piaskycrovalimab-akkz351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2686626crovalimab-akkz 340 MG in 2 ML InjectionPSN2597efc2-a97b-487c-b500-a67fd282a73b3
2686633Piasky 340 MG in 2 ML InjectionPSN2597efc2-a97b-487c-b500-a67fd282a73b3
26866332 ML crovalimab-akkz 170 MG/ML Injection [Piasky]SBD2597efc2-a97b-487c-b500-a67fd282a73b3
26866262 ML crovalimab-akkz 170 MG/ML InjectionSCD2597efc2-a97b-487c-b500-a67fd282a73b3
26866332 ML Piasky 170 MG/ML InjectionSY2597efc2-a97b-487c-b500-a67fd282a73b3
2686626crovalimab-akkz 340 MG per 2 ML InjectionSY2597efc2-a97b-487c-b500-a67fd282a73b3
2686633Piasky 340 MG per 2 ML InjectionSY2597efc2-a97b-487c-b500-a67fd282a73b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50242-115-01502420115011 VIAL, SINGLE-USE in 1 CARTON (50242-115-01) / 2 mL in 1 VIAL, SINGLE-USE2024-06-20NoNoCurrent