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  5. NDC Package Code: 14335-060-01 Esomeprazole Sodium

NDC Package 14335-060-01 Esomeprazole Sodium

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

Table of Contents

    1. Package Information
    2. 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:
14335-060-01
Package Description:
10 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code:
14335-060
Proprietary Name:
Esomeprazole Sodium
Non-Proprietary Name:
Esomeprazole Sodium
Substance Name:
Esomeprazole Sodium
Usage Information:
Esomeprazole sodium for injection is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)] . Proton pump inhibitors (PPIs), including esomeprazole sodium for injection, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)] .
11-Digit NDC Billing Format:
14335006001
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Hainan Poly Pharm. Co., Ltd.
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):
ESOMEPRAZOLE SODIUM 40 mg/5mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA215732
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-31-2021
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 14335-060-01?

The NDC Packaged Code 14335-060-01 is assigned to a package of 10 vial in 1 carton / 5 ml in 1 vial of Esomeprazole Sodium, a human prescription drug labeled by Hainan Poly Pharm. Co., Ltd.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

Is NDC 14335-060 included in the NDC Directory?

Yes, Esomeprazole Sodium with product code 14335-060 is active and included in the NDC Directory. The product was first marketed by Hainan Poly Pharm. Co., Ltd. on January 31, 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 11-digit format for NDC 14335-060-01?

The 11-digit format is 14335006001. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-214335-060-015-4-214335-0060-01