pyzchiva

Generic: ustekinumab-ttwe

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name pyzchiva
Generic Name ustekinumab-ttwe
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ustekinumab 45 mg/.5mL

Manufacturer
SANDOZ INC

Identifiers & Regulatory

Product NDC 61314-651
Product ID 61314-651_98db93b4-ea8b-4bec-b12c-c35937b42d68
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761373
Listing Expiration 2026-12-31
Marketing Start 2025-02-22

Pharmacologic Class

Established (EPC)
interleukin-12 antagonist [epc] interleukin-23 antagonist [epc]
Mechanism of Action
interleukin-12 antagonists [moa] interleukin-23 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314651
Hyphenated Format 61314-651

Supplemental Identifiers

RxCUI
2705557 2705564 2705568 2705573 2705575 2705576 2713885 2713887
UNII
FU77B4U5Z0
NUI
N0000192797 N0000192796 N0000192799 N0000192798

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pyzchiva (source: ndc)
Generic Name ustekinumab-ttwe (source: ndc)
Application Number BLA761373 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (61314-651-01) / .5 mL in 1 SYRINGE
  • 1 VIAL in 1 CARTON (61314-651-94) / .5 mL in 1 VIAL
source: ndc

Packages (2)

61314-651-01 1 SYRINGE in 1 CARTON (61314-651-01) / .5 mL in 1 SYRINGE 61314-651-94 1 VIAL in 1 CARTON (61314-651-94) / .5 mL in 1 VIAL

Ingredients (1)

ustekinumab (45 mg/.5mL)

Linked Drug Pages (1)

PYZCHIVA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "98db93b4-ea8b-4bec-b12c-c35937b42d68", "openfda": {"nui": ["N0000192797", "N0000192796", "N0000192799", "N0000192798"], "unii": ["FU77B4U5Z0"], "rxcui": ["2705557", "2705564", "2705568", "2705573", "2705575", "2705576", "2713885", "2713887"], "spl_set_id": ["e8a14922-7902-4d9f-8ba5-d91dccffed29"], "pharm_class_epc": ["Interleukin-12 Antagonist [EPC]", "Interleukin-23 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonists [MoA]"], "manufacturer_name": ["SANDOZ INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (61314-651-01)  / .5 mL in 1 SYRINGE", "package_ndc": "61314-651-01", "marketing_start_date": "20250222"}, {"sample": false, "description": "1 VIAL in 1 CARTON (61314-651-94)  / .5 mL in 1 VIAL", "package_ndc": "61314-651-94", "marketing_start_date": "20250623"}], "brand_name": "PYZCHIVA", "product_id": "61314-651_98db93b4-ea8b-4bec-b12c-c35937b42d68", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "61314-651", "generic_name": "ustekinumab-ttwe", "labeler_name": "SANDOZ INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PYZCHIVA", "active_ingredients": [{"name": "USTEKINUMAB", "strength": "45 mg/.5mL"}], "application_number": "BLA761373", "marketing_category": "BLA", "marketing_start_date": "20250222", "listing_expiration_date": "20261231"}