FDA.reportPublic FDA data

PYZCHIVA

Product NDC
61314-651
11-digit product format
613140651
Labeler code
61314
Product ID
61314-651_9238fa88-0b56-4490-9846-d55a823636f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-ttwe
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
SANDOZ INC
Application
BLA761373
Marketing category
BLA
Marketing start
2025-02-22
Substance
USTEKINUMAB
Active strength
45 mg/.5mL
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
USTEKINUMAB45 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2705557, 2705564, 2705568, 2705573, 2705575, 2705576, 2713885, 2713887

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9101c6a6-2dd0-4586-9db6-ccb20dc679c9Product name220171206
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-651-01PYZCHIVA0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.516
61314-651-01PYZCHIVA1 in 1 CARTONINJECTION, SOLUTION116
61314-651-94PYZCHIVA1 in 1 CARTONINJECTION, SOLUTION116
61314-651-94PYZCHIVA0.5 mL in 1 VIALINJECTION, SOLUTION0.516

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-651PYZCHIVA (USTEKINUMAB-TTWE) INJECTION, SOLUTION [SANDOZ INC]11Current NDC, 4 package rows20250515_e8a14922-7902-4d9f-8ba5-d91dccffed29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705564Pyzchiva 130 MG in 26 ML InjectionPSNe8a14922-7902-4d9f-8ba5-d91dccffed2916
2713887Pyzchiva 45 MG in 0.5 ML InjectionPSNe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705573Pyzchiva 45 MG in 0.5 ML Prefilled SyringePSNe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705576Pyzchiva 90 MG in 1 ML Prefilled SyringePSNe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705557ustekinumab-ttwe 130 MG in 26 ML InjectionPSNe8a14922-7902-4d9f-8ba5-d91dccffed2916
2713885ustekinumab-ttwe 45 MG in 0.5 ML InjectionPSNe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705568ustekinumab-ttwe 45 MG in 0.5 ML Prefilled SyringePSNe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705575ustekinumab-ttwe 90 MG in 1 ML Prefilled SyringePSNe8a14922-7902-4d9f-8ba5-d91dccffed2916
27138870.5 ML ustekinumab-ttwe 90 MG/ML Injection [Pyzchiva]SBDe8a14922-7902-4d9f-8ba5-d91dccffed2916
27055730.5 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe [Pyzchiva]SBDe8a14922-7902-4d9f-8ba5-d91dccffed2916
27055761 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe [Pyzchiva]SBDe8a14922-7902-4d9f-8ba5-d91dccffed2916
270556426 ML ustekinumab-ttwe 5 MG/ML Injection [Pyzchiva]SBDe8a14922-7902-4d9f-8ba5-d91dccffed2916
27138850.5 ML ustekinumab-ttwe 90 MG/ML InjectionSCDe8a14922-7902-4d9f-8ba5-d91dccffed2916
27055680.5 ML ustekinumab-ttwe 90 MG/ML Prefilled SyringeSCDe8a14922-7902-4d9f-8ba5-d91dccffed2916
27055751 ML ustekinumab-ttwe 90 MG/ML Prefilled SyringeSCDe8a14922-7902-4d9f-8ba5-d91dccffed2916
270555726 ML ustekinumab-ttwe 5 MG/ML InjectionSCDe8a14922-7902-4d9f-8ba5-d91dccffed2916
27055730.5 ML Pyzchiva 90 MG/ML Prefilled SyringeSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
27055761 ML Pyzchiva 90 MG/ML Prefilled SyringeSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
270556426 ML Pyzchiva 5 MG/ML InjectionSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705564Pyzchiva 130 MG per 26 ML InjectionSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
2713887Pyzchiva 45 MG per 0.5 ML InjectionSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705573Pyzchiva 45 MG per 0.5 ML Prefilled SyringeSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705576Pyzchiva 90 MG per 1 ML Prefilled SyringeSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705557ustekinumab-ttwe 130 MG per 26 ML InjectionSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
2713885ustekinumab-ttwe 45 MG per 0.5 ML InjectionSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705568ustekinumab-ttwe 45 MG per 0.5 ML Prefilled SyringeSYe8a14922-7902-4d9f-8ba5-d91dccffed2916
2705575ustekinumab-ttwe 90 MG per 1 ML Prefilled SyringeSYe8a14922-7902-4d9f-8ba5-d91dccffed2916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61314-651-01613140651011 SYRINGE in 1 CARTON (61314-651-01) / .5 mL in 1 SYRINGE1 syringe2025-02-22NoNoCurrent
61314-651-94613140651941 VIAL in 1 CARTON (61314-651-94) / .5 mL in 1 VIAL1 vial2025-06-23NoNoCurrent