Ilumya Injection, Solution
NDC Package 47335-177-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ilumya (tildrakizumab-asmn) injection is a medication used to treat moderate to severe plaque psoriasis. This formulation utilizes a injection, solution delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-177 and is authorized under FDA application BLA761067.

Identification & Billing

NDC Package Code
47335-177-01
Package Description
1 mL in 1 SYRINGE, GLASS
Product Code
47335-177
11-Digit Billing Format
47335017701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ilumya
Non-Proprietary Name
Tildrakizumab-asmn
Substance Name
Tildrakizumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
TILDRAKIZUMAB 100 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat moderate to severe plaque psoriasis. Tildrakizumab-asmn belongs to a class of drugs known as monoclonal antibodies. It works by blocking a certain natural substance in your body (interleukin-23) that may lead to the overgrowth of skin cells and redness/swelling seen in plaque psoriasis. Tildrakizumab-asmn can help lessen the symptoms of plaque psoriasis, including red, scaly, itchy patches of skin.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761067
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-06-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (47335-177). Click a package code to view its specific billing and regulatory data.

47335-177-10
1 mL in 1 CARTON
47335-177-95
1 mL in 1 CARTON
47335-177-96
1 mL in 1 SYRINGE, GLASS

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 47335-177-01 identifies a specific commercial package of 1 ml in 1 syringe, glass of Ilumya, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This injection, solution is formulated for subcutaneous use and contains tildrakizumab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sun Pharmaceutical Industries, Inc. on August 06, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat moderate to severe plaque psoriasis. Tildrakizumab-asmn belongs to a class of drugs known as monoclonal antibodies. It works by blocking a certain natural substance in your body (interleukin-23) that may lead to the overgrowth of skin cells and redness/swelling seen in plaque psoriasis. Tildrakizumab-asmn can help lessen the symptoms of plaque psoriasis, including red, scaly, itchy patches of skin.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335017701. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
47335-177-01
11-Digit CMS (5-4-2)
47335-0177-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.