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  5. NDC Package Code: 33342-307-07 Esomeprazole

NDC Package 33342-307-07 Esomeprazole

Capsule, Delayed Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
33342-307-07
Package Description:
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code:
33342-307
Proprietary Name:
Esomeprazole
Non-Proprietary Name:
Esomeprazole
Substance Name:
Esomeprazole
Usage Information:
• Esomeprazole magnesium 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)]. • For information about contraindications of amoxicillin and clarithromycin, indicated in combination with esomeprazole magnesium for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications  section of the respective prescribing information. • Proton pump inhibitors (PPIs), including esomeprazole magnesium are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].
11-Digit NDC Billing Format:
33342030707
NDC to RxNorm Crosswalk:
  • RxCUI: 606726 - esomeprazole magnesium 20 MG Delayed Release Oral Capsule
  • RxCUI: 606726 - esomeprazole 20 MG Delayed Release Oral Capsule
  • RxCUI: 606726 - esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule
  • RxCUI: 606726 - esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule
  • RxCUI: 606730 - esomeprazole magnesium 40 MG Delayed Release Oral Capsule
Product Type:
Human Prescription Drug
Labeler Name:
Macleods Pharmaceuticals Limited
Dosage Form:
Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
ESOMEPRAZOLE 40 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA208511
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
10-23-2024
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
33342-307-1090 CAPSULE, DELAYED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 33342-307-07?

The NDC Packaged Code 33342-307-07 is assigned to a package of 30 capsule, delayed release in 1 bottle of Esomeprazole, a human prescription drug labeled by Macleods Pharmaceuticals Limited. The product's dosage form is capsule, delayed release and is administered via oral form.

Is NDC 33342-307 included in the NDC Directory?

Yes, Esomeprazole with product code 33342-307 is active and included in the NDC Directory. The product was first marketed by Macleods Pharmaceuticals Limited on October 23, 2024 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 33342-307-07?

The 11-digit format is 33342030707. 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
5-3-233342-307-075-4-233342-0307-07