PYZCHIVA

Product NDC: 83457-651
11-digit product format: 834570651
Labeler code: 83457
Product ID: 83457-651_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: 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
Ingredient	Strength
USTEKINUMAB	45 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FU77B4U5Z0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f356501d-1347-4557-a252-c2d9f1b2dcb2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9101c6a6-2dd0-4586-9db6-ccb20dc679c9	Product name	2	20171206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83457-651-01	PYZCHIVA	0.5 mL in 1 SYRINGE	INJECTION, SOLUTION	0.5	6
83457-651-01	PYZCHIVA	1 in 1 CARTON	INJECTION, SOLUTION	1	6
83457-651-96	PYZCHIVA	0.5 mL in 1 SYRINGE	INJECTION, SOLUTION	0.5	6
83457-651-96	PYZCHIVA	1 in 1 CARTON	INJECTION, SOLUTION	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83457-651-01	ML - Milliliter	83457-651	089378d7-f4b1-4217-85a1-7aa849897dfd	1	2025-06-13
83457-651-96	ML - Milliliter	83457-651	a3c7b2ce-46e7-46ac-b385-97f9242c4e8b	1	2025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83457-651	PYZCHIVA (USTEKINUMAB-TTWE) INJECTION, SOLUTION [CORDAVIS LIMITED]	1	Current NDC, 4 package rows	20250511_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PYZCHIVA	USTEKINUMAB-TTWE	SANDOZ INC	e8a14922-7902-4d9f-8ba5-d91dccffed29	2026-07-09	Warnings, Adverse reactions	Exact identifier application number: BLA761373
PYZCHIVA	USTEKINUMAB-TTWE	Cordavis Limited	f356501d-1347-4557-a252-c2d9f1b2dcb2	2026-07-09	Warnings, Adverse reactions	Exact identifier application number: BLA761373 ndc (product): 83457-651
USTEKINUMAB-TTWE	USTEKINUMAB-TTWE	Quallent Pharmaceuticals Health LLC	2b34392a-ecf6-41bd-8706-d4e9f0b25da8	2026-01-12	Warnings, Adverse reactions	Exact identifier application number: BLA761373

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761373	Pyzchiva	ustekinumab-ttwe	351(k) Interchangeable	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FU77B4U5Z0	USTEKINUMAB	815610-63-0	USTEKINUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2720516	Pyzchiva 45 MG in 0.5 ML Auto-Injector	PSN	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705573	Pyzchiva 45 MG in 0.5 ML Prefilled Syringe	PSN	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2721431	Pyzchiva 90 MG in 1 ML Auto-Injector	PSN	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705576	Pyzchiva 90 MG in 1 ML Prefilled Syringe	PSN	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2720512	ustekinumab-ttwe 45 MG in 0.5 ML Auto-Injector	PSN	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705568	ustekinumab-ttwe 45 MG in 0.5 ML Prefilled Syringe	PSN	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2721430	ustekinumab-ttwe 90 MG in 1 ML Auto-Injector	PSN	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705575	ustekinumab-ttwe 90 MG in 1 ML Prefilled Syringe	PSN	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2720516	0.5 ML ustekinumab-ttwe 90 MG/ML Auto-Injector [Pyzchiva]	SBD	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705573	0.5 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe [Pyzchiva]	SBD	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2721431	1 ML ustekinumab-ttwe 90 MG/ML Auto-Injector [Pyzchiva]	SBD	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705576	1 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe [Pyzchiva]	SBD	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2720512	0.5 ML ustekinumab-ttwe 90 MG/ML Auto-Injector	SCD	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705568	0.5 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe	SCD	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2721430	1 ML ustekinumab-ttwe 90 MG/ML Auto-Injector	SCD	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705575	1 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe	SCD	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705573	0.5 ML Pyzchiva 90 MG/ML Prefilled Syringe	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705576	1 ML Pyzchiva 90 MG/ML Prefilled Syringe	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2720516	Pyzchiva 45 MG per 0.5 ML Auto-Injector	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705573	Pyzchiva 45 MG per 0.5 ML Prefilled Syringe	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2721431	Pyzchiva 90 MG per 1 ML Auto-Injector	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705576	Pyzchiva 90 MG per 1 ML Prefilled Syringe	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2720516	Pyzchiva 90 MG/ML per 0.5 ML Auto-Injector	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2721431	Pyzchiva 90 MG/ML per 1 ML Auto-Injector	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2720512	ustekinumab-ttwe 45 MG per 0.5 ML Auto-Injector	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705568	ustekinumab-ttwe 45 MG per 0.5 ML Prefilled Syringe	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2721430	ustekinumab-ttwe 90 MG per 1 ML Auto-Injector	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2705575	ustekinumab-ttwe 90 MG per 1 ML Prefilled Syringe	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2720512	ustekinumab-ttwe 90 MG/ML per 0.5 ML Auto-Injector	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6
2721430	ustekinumab-ttwe 90 MG/ML per 1 ML Auto-Injector	SY	f356501d-1347-4557-a252-c2d9f1b2dcb2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83457-651-01	83457065101	1 SYRINGE in 1 CARTON (83457-651-01) / .5 mL in 1 SYRINGE	1 syringe	2025-05-01	No	No	Current
83457-651-96	83457065196	1 SYRINGE in 1 CARTON (83457-651-96) / .5 mL in 1 SYRINGE	1 syringe	2025-08-14	No	No	Current