imuldosa

Generic: ustekinumab-srlf

Labeler: accord biopharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name imuldosa
Generic Name ustekinumab-srlf
Labeler accord biopharma inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

ustekinumab-srlf 45 mg/.5mL

Manufacturer
Accord BioPharma Inc.

Identifiers & Regulatory

Product NDC 69448-017
Product ID 69448-017_450dafe8-f537-6303-e063-6394a90aa784
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761364
Listing Expiration 2026-12-31
Marketing Start 2024-10-14

Pharmacologic Class

Classes
interleukin-12 antagonist [epc] interleukin-12 antagonists [moa] interleukin-23 antagonist [epc] interleukin-23 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69448017
Hyphenated Format 69448-017

Supplemental Identifiers

RxCUI
2717067 2717074 2717078 2717083 2717085 2717086
UNII
FU77B4U5Z0

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 imuldosa (source: ndc)
Generic Name ustekinumab-srlf (source: ndc)
Application Number BLA761364 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/.5mL
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (69448-017-63) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
source: ndc

Packages (1)

69448-017-63 1 BLISTER PACK in 1 CARTON (69448-017-63) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE

Ingredients (1)

ustekinumab-srlf (45 mg/.5mL)

Linked Drug Pages (1)

IMULDOSA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "450dafe8-f537-6303-e063-6394a90aa784", "openfda": {"unii": ["FU77B4U5Z0"], "rxcui": ["2717067", "2717074", "2717078", "2717083", "2717085", "2717086"], "spl_set_id": ["2539a6cf-0fe5-1565-e063-6294a90a3618"], "manufacturer_name": ["Accord BioPharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69448-017-63)  / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE", "package_ndc": "69448-017-63", "marketing_start_date": "20241014"}], "brand_name": "IMULDOSA", "product_id": "69448-017_450dafe8-f537-6303-e063-6394a90aa784", "dosage_form": "INJECTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "69448-017", "generic_name": "ustekinumab-srlf", "labeler_name": "Accord BioPharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMULDOSA", "active_ingredients": [{"name": "USTEKINUMAB-SRLF", "strength": "45 mg/.5mL"}], "application_number": "BLA761364", "marketing_category": "BLA", "marketing_start_date": "20241014", "listing_expiration_date": "20261231"}