FDA.reportPublic FDA data

USTEKINUMAB-TTWE

Product NDC
82009-160
11-digit product format
820090160
Labeler code
82009
Product ID
82009-160_cb6d8d30-9458-42ed-8aee-2aae13f4760b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-ttwe
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Quallent Pharmaceuticals Health LLC
Application
BLA761373
Marketing category
BLA
Marketing start
2025-04-15
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
USTEKINUMAB-TTWE
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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2705557Internal RxNorm lookup
2705568Internal RxNorm lookup
2705575Internal RxNorm lookup
2713885Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b34392a-ecf6-41bd-8706-d4e9f0b25da8Available 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
82009-160-11USTEKINUMAB-TTWE0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.56
82009-160-11USTEKINUMAB-TTWE1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-160-11ML - Milliliter82009-160de18f1a3-4818-4126-bde0-39b9991db55d12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-160USTEKINUMAB-TTWE INJECTION, SOLUTION [QUALLENT PHARMACEUTICALS HEALTH LLC]3Current NDC, 2 package rows20250416_2b34392a-ecf6-41bd-8706-d4e9f0b25da8.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
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
ndc (product): 82009-160

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
2705557ustekinumab-ttwe 130 MG in 26 ML InjectionPSN2b34392a-ecf6-41bd-8706-d4e9f0b25da86
2713885ustekinumab-ttwe 45 MG in 0.5 ML InjectionPSN2b34392a-ecf6-41bd-8706-d4e9f0b25da86
2705568ustekinumab-ttwe 45 MG in 0.5 ML Prefilled SyringePSN2b34392a-ecf6-41bd-8706-d4e9f0b25da86
2705575ustekinumab-ttwe 90 MG in 1 ML Prefilled SyringePSN2b34392a-ecf6-41bd-8706-d4e9f0b25da86
27138850.5 ML ustekinumab-ttwe 90 MG/ML InjectionSCD2b34392a-ecf6-41bd-8706-d4e9f0b25da86
27055680.5 ML ustekinumab-ttwe 90 MG/ML Prefilled SyringeSCD2b34392a-ecf6-41bd-8706-d4e9f0b25da86
27055751 ML ustekinumab-ttwe 90 MG/ML Prefilled SyringeSCD2b34392a-ecf6-41bd-8706-d4e9f0b25da86
270555726 ML ustekinumab-ttwe 5 MG/ML InjectionSCD2b34392a-ecf6-41bd-8706-d4e9f0b25da86
2705557ustekinumab-ttwe 130 MG per 26 ML InjectionSY2b34392a-ecf6-41bd-8706-d4e9f0b25da86
2713885ustekinumab-ttwe 45 MG per 0.5 ML InjectionSY2b34392a-ecf6-41bd-8706-d4e9f0b25da86
2705568ustekinumab-ttwe 45 MG per 0.5 ML Prefilled SyringeSY2b34392a-ecf6-41bd-8706-d4e9f0b25da86
2705575ustekinumab-ttwe 90 MG per 1 ML Prefilled SyringeSY2b34392a-ecf6-41bd-8706-d4e9f0b25da86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82009-160-11820090160111 SYRINGE in 1 CARTON (82009-160-11) / .5 mL in 1 SYRINGE1 syringe2025-04-15NoNoCurrent