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 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
2705557Internal RxNorm lookup
2705564Internal RxNorm lookup
2705568Internal RxNorm lookup
2705573Internal RxNorm lookup
2705575Internal RxNorm lookup
2705576Internal RxNorm lookup
2713885Internal RxNorm lookup
2713887Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8a14922-7902-4d9f-8ba5-d91dccffed29Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-651-01ML - Milliliter61314-651ae67f020-3d06-450f-a071-c9b5fcafc2ce12025-03-04
61314-651-94ML - Milliliter61314-651293c6b46-da8b-4ee7-9c38-db616e6a5d3612025-07-08

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

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
ndc (product): 61314-651
PYZCHIVAUSTEKINUMAB-TTWECordavis Limitedf356501d-1347-4557-a252-c2d9f1b2dcb22026-07-09Warnings, Adverse reactionsExact identifier
application number: BLA761373
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
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