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 Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2705568, 2705573, 2705575, 2705576, 2720512, 2720516, 2721430, 2721431

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

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 syringe2025-05-01NoNoHistorical
83457-652-96834570652961 SYRINGE in 1 CARTON (83457-652-96) / 1 mL in 1 SYRINGE1 syringe2025-08-14NoNoHistorical