FDA.reportPublic FDA data

USTEKINUMAB-TTWE

Product NDC
82009-163
11-digit product format
820090163
Labeler code
82009
Product ID
82009-163_cb6d8d30-9458-42ed-8aee-2aae13f4760b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-ttwe
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Quallent Pharmaceuticals Health LLC
Application
BLA761425
Marketing category
BLA
Marketing start
2025-04-15
Substance
USTEKINUMAB
Active strength
130 mg/26mL
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
USTEKINUMAB130 mg/26mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2705557, 2705568, 2705575, 2713885

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
82009-163-94USTEKINUMAB-TTWE26 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION266
82009-163-94USTEKINUMAB-TTWE1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-163-94ML - Milliliter82009-163576948f8-77c9-484f-90c3-3afff810df1712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-163USTEKINUMAB-TTWE INJECTION, SOLUTION [QUALLENT PHARMACEUTICALS HEALTH LLC]3Current NDC, 2 package rows20250416_2b34392a-ecf6-41bd-8706-d4e9f0b25da8.zip

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 formatDescriptionMarketing startSampleExclude flagStatus
82009-163-94820090163941 VIAL, SINGLE-USE in 1 CARTON (82009-163-94) / 26 mL in 1 VIAL, SINGLE-USE2025-04-15NoNoCurrent