Omeprazole
NDC Package 51138-101-30
Package Information
Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). Marketed by Med-health Pharma, Llc, this product is identified by NDC 51138-101 and is authorized under FDA application ANDA075410.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 51138 - Med-health Pharma, Llc
- 51138-101 - Omeprazole
- 51138-101-30 - 30 CAPSULE in 1 BOTTLE
- 51138-101 - Omeprazole
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 51138-101-30 identifies a specific commercial package of 30 capsule in 1 bottle of Omeprazole Delayed-release, labeled by Med-health Pharma, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Med-health Pharma, Llc on January 30, 2011. The current certification is valid through October 15, 2012.
What are the primary indications for this medication?
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.
How is this Med-health Pharma, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 51138010130. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.