NDC Package 71336-1001-1 Givlaari

Givosiran Sodium Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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

Proprietary Name:

Givlaari

Non-Proprietary Name:

Givosiran Sodium

Substance Name:

Givosiran Sodium

Usage Information:

GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP).

11-Digit NDC Billing Format:

71336100101

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 2265716 - givosiran 189 MG in 1 ML Injection

RxCUI: 2265716 - 1 ML givosiran 189 MG/ML Injection

RxCUI: 2265716 - givosiran 189 MG per 1 ML Injection

RxCUI: 2265721 - GIVLAARI 189 MG in 1 ML Injection

RxCUI: 2265721 - 1 ML givosiran 189 MG/ML Injection [Givlaari]

Product Type:

Human Prescription Drug

Labeler Name:

Alnylam Pharmaceuticals, Inc.

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(s):

Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Active Ingredient(s):

GIVOSIRAN SODIUM 189 mg/mL

Sample Package:

FDA Application Number:

NDA212194

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

12-12-2019

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

71336 - Alnylam Pharmaceuticals, Inc.
- 71336-1001 - Givlaari
  - 71336-1001-1 - 1 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE

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 disclaimer below.

Frequently Asked Questions

What is NDC 71336-1001-1?

The NDC Packaged Code 71336-1001-1 is assigned to a 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.. The product's dosage form is injection, solution and is administered via subcutaneous form.

Is NDC 71336-1001 included in the NDC Directory?

Yes, Givlaari with product code 71336-1001 is active and included in the NDC Directory. The product was first marketed by Alnylam Pharmaceuticals, Inc. on December 12, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 71336-1001-1?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 71336-1001-1?

The 11-digit format is 71336100101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	71336-1001-1	5-4-2	71336-1001-01

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