FDA.reportPublic FDA data

PYZCHIVA

Product NDC
83457-652
11-digit product format
834570652
Labeler code
83457
Product ID
83457-652_7604db31-ef63-4200-8675-bacbbbd09d50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-ttwe
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Cordavis Limited
Application
BLA761373
Marketing category
BLA
Marketing start
2025-05-01
Substance
USTEKINUMAB
Active strength
90 mg/mL
Pharmacologic classes
Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB90 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FU77B4U5Z0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2705568Internal RxNorm lookup
2705573Internal RxNorm lookup
2705575Internal RxNorm lookup
2705576Internal RxNorm lookup
2720512Internal RxNorm lookup
2720516Internal RxNorm lookup
2721430Internal RxNorm lookup
2721431Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f356501d-1347-4557-a252-c2d9f1b2dcb2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9101c6a6-2dd0-4586-9db6-ccb20dc679c9Product name220171206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83457-652-01PYZCHIVA1 mL in 1 SYRINGEINJECTION, SOLUTION16
83457-652-01PYZCHIVA1 in 1 CARTONINJECTION, SOLUTION16
83457-652-96PYZCHIVA1 mL in 1 SYRINGEINJECTION, SOLUTION16
83457-652-96PYZCHIVA1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83457-652-01ML - Milliliter83457-65257f79038-1eac-4c7c-aa5d-6f8f835304b812025-06-13
83457-652-96ML - Milliliter83457-6528e0ce6fc-aab6-4d53-a8d7-a5201036a82c12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83457-652PYZCHIVA (USTEKINUMAB-TTWE) INJECTION, SOLUTION [CORDAVIS LIMITED]1Current NDC, 4 package rows20250511_f356501d-1347-4557-a252-c2d9f1b2dcb2.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PYZCHIVAUSTEKINUMAB-TTWESANDOZ INCe8a14922-7902-4d9f-8ba5-d91dccffed292026-07-09Warnings, Adverse reactionsExact identifier
application number: BLA761373
PYZCHIVAUSTEKINUMAB-TTWECordavis Limitedf356501d-1347-4557-a252-c2d9f1b2dcb22026-07-09Warnings, Adverse reactionsExact identifier
application number: BLA761373
ndc (product): 83457-652
USTEKINUMAB-TTWEUSTEKINUMAB-TTWEQuallent Pharmaceuticals Health LLC2b34392a-ecf6-41bd-8706-d4e9f0b25da82026-01-12Warnings, Adverse reactionsExact identifier
application number: BLA761373

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761373Pyzchivaustekinumab-ttwe351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2720516Pyzchiva 45 MG in 0.5 ML Auto-InjectorPSNf356501d-1347-4557-a252-c2d9f1b2dcb26
2705573Pyzchiva 45 MG in 0.5 ML Prefilled SyringePSNf356501d-1347-4557-a252-c2d9f1b2dcb26
2721431Pyzchiva 90 MG in 1 ML Auto-InjectorPSNf356501d-1347-4557-a252-c2d9f1b2dcb26
2705576Pyzchiva 90 MG in 1 ML Prefilled SyringePSNf356501d-1347-4557-a252-c2d9f1b2dcb26
2720512ustekinumab-ttwe 45 MG in 0.5 ML Auto-InjectorPSNf356501d-1347-4557-a252-c2d9f1b2dcb26
2705568ustekinumab-ttwe 45 MG in 0.5 ML Prefilled SyringePSNf356501d-1347-4557-a252-c2d9f1b2dcb26
2721430ustekinumab-ttwe 90 MG in 1 ML Auto-InjectorPSNf356501d-1347-4557-a252-c2d9f1b2dcb26
2705575ustekinumab-ttwe 90 MG in 1 ML Prefilled SyringePSNf356501d-1347-4557-a252-c2d9f1b2dcb26
27205160.5 ML ustekinumab-ttwe 90 MG/ML Auto-Injector [Pyzchiva]SBDf356501d-1347-4557-a252-c2d9f1b2dcb26
27055730.5 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe [Pyzchiva]SBDf356501d-1347-4557-a252-c2d9f1b2dcb26
27214311 ML ustekinumab-ttwe 90 MG/ML Auto-Injector [Pyzchiva]SBDf356501d-1347-4557-a252-c2d9f1b2dcb26
27055761 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe [Pyzchiva]SBDf356501d-1347-4557-a252-c2d9f1b2dcb26
27205120.5 ML ustekinumab-ttwe 90 MG/ML Auto-InjectorSCDf356501d-1347-4557-a252-c2d9f1b2dcb26
27055680.5 ML ustekinumab-ttwe 90 MG/ML Prefilled SyringeSCDf356501d-1347-4557-a252-c2d9f1b2dcb26
27214301 ML ustekinumab-ttwe 90 MG/ML Auto-InjectorSCDf356501d-1347-4557-a252-c2d9f1b2dcb26
27055751 ML ustekinumab-ttwe 90 MG/ML Prefilled SyringeSCDf356501d-1347-4557-a252-c2d9f1b2dcb26
27055730.5 ML Pyzchiva 90 MG/ML Prefilled SyringeSYf356501d-1347-4557-a252-c2d9f1b2dcb26
27055761 ML Pyzchiva 90 MG/ML Prefilled SyringeSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2720516Pyzchiva 45 MG per 0.5 ML Auto-InjectorSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2705573Pyzchiva 45 MG per 0.5 ML Prefilled SyringeSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2721431Pyzchiva 90 MG per 1 ML Auto-InjectorSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2705576Pyzchiva 90 MG per 1 ML Prefilled SyringeSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2720516Pyzchiva 90 MG/ML per 0.5 ML Auto-InjectorSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2721431Pyzchiva 90 MG/ML per 1 ML Auto-InjectorSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2720512ustekinumab-ttwe 45 MG per 0.5 ML Auto-InjectorSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2705568ustekinumab-ttwe 45 MG per 0.5 ML Prefilled SyringeSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2721430ustekinumab-ttwe 90 MG per 1 ML Auto-InjectorSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2705575ustekinumab-ttwe 90 MG per 1 ML Prefilled SyringeSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2720512ustekinumab-ttwe 90 MG/ML per 0.5 ML Auto-InjectorSYf356501d-1347-4557-a252-c2d9f1b2dcb26
2721430ustekinumab-ttwe 90 MG/ML per 1 ML Auto-InjectorSYf356501d-1347-4557-a252-c2d9f1b2dcb26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83457-652-01834570652011 SYRINGE in 1 CARTON (83457-652-01) / 1 mL in 1 SYRINGE1 syringe2025-05-01NoNoCurrent
83457-652-96834570652961 SYRINGE in 1 CARTON (83457-652-96) / 1 mL in 1 SYRINGE1 syringe2025-08-14NoNoCurrent