NDC Package 0069-0308-01 Trazimera

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

Package Information
NDC HCPCS Crosswalk
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:

0069-0308-01

Package Description:

1 VIAL in 1 CARTON / 7.15 mL in 1 VIAL

Product Code:

0069-0308

Proprietary Name:

Trazimera

Non-Proprietary Name:

Trastuzumab-qyyp

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:

00069030801

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

1 EA

NDC to RxNorm Crosswalk:

RxCUI: 2280732 - trastuzumab-qyyp 420 MG in 20 ML Injectable Solution
RxCUI: 2280732 - trastuzumab-qyyp 21 MG/ML Injectable Solution
RxCUI: 2280732 - trastuzumab-qyyp 420 MG per 20 ML Injectable Solution
RxCUI: 2280737 - Trazimera 420 MG in 20 mL Injectable Solution
RxCUI: 2280737 - trastuzumab-qyyp 21 MG/ML Injectable Solution [Trazimera]

Product Type:

Human Prescription Drug

Labeler Name:

Pfizer Laboratories Div Pfizer 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 150 mg/7.15mL

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

BLA761081

Marketing Category:

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

Start Marketing Date:

03-10-2021

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

0069 - Pfizer Laboratories Div Pfizer Inc
- 0069-0308 - Trazimera
  - 0069-0308-01 - 1 VIAL in 1 CARTON / 7.15 mL in 1 VIAL

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.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0069-0308-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
00069030801	Q5116	Inj., trazimera, 10 mg	10 MG	1	1	15	15

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0069-0308-01?

The NDC Packaged Code 0069-0308-01 is assigned to a package of 1 vial in 1 carton / 7.15 ml in 1 vial of Trazimera, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 0069-0308 included in the NDC Directory?

Yes, Trazimera with product code 0069-0308 is active and included in the NDC Directory. The product was first marketed by Pfizer Laboratories Div Pfizer Inc on March 10, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0069-0308-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 0069-0308-01?

The 11-digit format is 00069030801. 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 4-4-2 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
4-4-2	0069-0308-01	5-4-2	00069-0308-01

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