NDC Package 55513-132-21 Kanjinti

Trastuzumab-anns Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information
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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:

55513-132-21

Package Description:

1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE

Product Code:

55513-132

Proprietary Name:

Kanjinti

Non-Proprietary Name:

Trastuzumab-anns

Substance Name:

Trastuzumab

Usage Information:

Trastuzumab is used to treat certain breast or stomach cancers that produce more than the normal amount of a certain substance called HER2 protein. Trastuzumab belongs to a class of medications known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. This monograph is about the following trastuzumab products: trastuzumab, trastuzumab-anns, trastuzumab-dkst, trastuzumab-dttb, trastuzumab-pkrb, trastuzumab-qyyp.

11-Digit NDC Billing Format:

55513013221

NDC to RxNorm Crosswalk:

RxCUI: 2174804 - trastuzumab-anns 420 MG in 20 mL Injectable Solution
RxCUI: 2174804 - trastuzumab-anns 21 MG/ML Injectable Solution
RxCUI: 2174804 - trastuzumab-anns 420 MG per 20 ML Injectable Solution
RxCUI: 2174809 - KANJINTI 420 MG in 20 mL Injectable Solution
RxCUI: 2174809 - trastuzumab-anns 21 MG/ML Injectable Solution [Kanjinti]

Product Type:

Human Prescription Drug

Labeler Name:

Amgen, Inc

Dosage Form:

Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.

Administration Route(s):

Intravenous - Administration within or into a vein or veins.

Active Ingredient(s):

TRASTUZUMAB 420 mg/20mL

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

BLA761073

Marketing Category:

BLA - A product marketed under an approved Biologic License Application.

Start Marketing Date:

06-11-2019

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

55513 - Amgen, Inc
- 55513-132 - Kanjinti
  - 55513-132-21 - 1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
55513-132-01	1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 55513-132-21?

The NDC Packaged Code 55513-132-21 is assigned to a package of 1 vial, multi-dose in 1 carton / 20 ml in 1 vial, multi-dose of Kanjinti, a human prescription drug labeled by Amgen, Inc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

Is NDC 55513-132 included in the NDC Directory?

Yes, Kanjinti with product code 55513-132 is active and included in the NDC Directory. The product was first marketed by Amgen, Inc on June 11, 2019 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 55513-132-21?

The 11-digit format is 55513013221. 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 5-3-2 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
5-3-2	55513-132-21	5-4-2	55513-0132-21

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