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  5. NDC Package Code: 55111-397-89 Omeprazole Magnesium

NDC Package 55111-397-89 Omeprazole Magnesium

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:
55111-397-89
Package Description:
1500 CAPSULE, DELAYED RELEASE in 1 POUCH
Product Code:
55111-397
Proprietary Name:
Omeprazole Magnesium
Non-Proprietary Name:
Omeprazole Magnesium
Substance Name:
Omeprazole Magnesium
Usage Information:
Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter omeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
11-Digit NDC Billing Format:
55111039789
Product Type:
Human Otc Drug
Labeler Name:
Dr. Reddy's Laboratories 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):
  • OMEPRAZOLE MAGNESIUM 20 mg/1
  • OMEPRAZOLE MAGNESIUM 20 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
  • Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    N/A
    FDA Application Number:
    ANDA078878
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-01-2010
    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
    55111-397-272 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
    55111-397-282 CARTON in 1 CARTON / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
    55111-397-333 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
    55111-397-393 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
    55111-397-423 CARTON in 1 CARTON / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
    55111-397-521 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 55111-397-89?

    The NDC Packaged Code 55111-397-89 is assigned to a package of 1500 capsule, delayed release in 1 pouch of Omeprazole Magnesium, a human over the counter drug labeled by Dr. Reddy's Laboratories Limited. The product's dosage form is capsule, delayed release and is administered via oral form.

    Is NDC 55111-397 included in the NDC Directory?

    Yes, Omeprazole Magnesium with product code 55111-397 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy's Laboratories Limited on March 01, 2010 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 55111-397-89?

    The 11-digit format is 55111039789. 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
    5-3-255111-397-895-4-255111-0397-89