ustekinumab-ttwe

Generic: ustekinumab-ttwe

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ustekinumab-ttwe
Generic Name ustekinumab-ttwe
Labeler quallent pharmaceuticals health llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ustekinumab 130 mg/26mL

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-163
Product ID 82009-163_cb6d8d30-9458-42ed-8aee-2aae13f4760b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761425
Listing Expiration 2027-12-31
Marketing Start 2025-04-15

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 82009163
Hyphenated Format 82009-163

Supplemental Identifiers

RxCUI
2705557 2705568 2705575 2713885
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 ustekinumab-ttwe (source: ndc)
Generic Name ustekinumab-ttwe (source: ndc)
Application Number BLA761425 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 130 mg/26mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (82009-163-94) / 26 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

82009-163-94 1 VIAL, SINGLE-USE in 1 CARTON (82009-163-94) / 26 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

ustekinumab (130 mg/26mL)

Linked Drug Pages (1)

USTEKINUMAB-TTWE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "cb6d8d30-9458-42ed-8aee-2aae13f4760b", "openfda": {"nui": ["N0000192797", "N0000192796", "N0000192799", "N0000192798"], "unii": ["FU77B4U5Z0"], "rxcui": ["2705557", "2705568", "2705575", "2713885"], "spl_set_id": ["2b34392a-ecf6-41bd-8706-d4e9f0b25da8"], "pharm_class_epc": ["Interleukin-12 Antagonist [EPC]", "Interleukin-23 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonists [MoA]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (82009-163-94)  / 26 mL in 1 VIAL, SINGLE-USE", "package_ndc": "82009-163-94", "marketing_start_date": "20250415"}], "brand_name": "USTEKINUMAB-TTWE", "product_id": "82009-163_cb6d8d30-9458-42ed-8aee-2aae13f4760b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "82009-163", "generic_name": "ustekinumab-ttwe", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "USTEKINUMAB-TTWE", "active_ingredients": [{"name": "USTEKINUMAB", "strength": "130 mg/26mL"}], "application_number": "BLA761425", "marketing_category": "BLA", "marketing_start_date": "20250415", "listing_expiration_date": "20271231"}