Givlaari Injection, Solution
NDC Package 71336-1001-1

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

Package Information

Givlaari (givosiran sodium) injection is gIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP). This formulation utilizes a injection, solution delivery system. Marketed by Alnylam Pharmaceuticals, Inc., this product is identified by NDC 71336-1001 and is authorized under FDA application NDA212194.

Identification & Billing

NDC Package Code
71336-1001-1
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE
Product Code
71336-1001
11-Digit Billing Format
71336100101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Givlaari
Non-Proprietary Name
Givosiran Sodium
Substance Name
Givosiran Sodium
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)
GIVOSIRAN SODIUM 189 mg/mL
Pharmacologic Class
Usage Information
GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP).

Regulatory & Marketing

Labeler Name
Alnylam Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212194
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-12-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0223
Source: ASP
Inj givosiran 0.5 mg
HCPCS Dosage 0.5 MG
Units / Pkg 378

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 71336-1001-1 identifies a specific commercial package of 1 vial, single-use in 1 carton / 1 ml in 1 vial, single-use of Givlaari, a human prescription drug labeled by Alnylam Pharmaceuticals, Inc.. This injection, solution is formulated for subcutaneous use and contains givosiran sodium 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 Alnylam Pharmaceuticals, Inc. on December 12, 2019. The current certification is valid through December 31, 2026.

How is this Alnylam Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71336100101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
71336-1001-1
11-Digit CMS (5-4-2)
71336-1001-01

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