Omeprazole And Sodium Bicarbonate Capsule, Gelatin Coated
NDC Package 41250-938-03
Package Information
Omeprazole And Sodium Bicarbonate (omeprazole, sodium bicarbonate) capsules is •for adults 18 years of age and older•this product is to be used once a day (every 24 hours), every day for 14 days•it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment•swallow 1 capsule with a glass of water at least 1 hour before eating in the morning•take every day for 14 days•do not take more than 1 capsule a day•do not chew or crush the capsule•do not open capsule and sprinkle on food•do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)•you may repeat a 14-day course every 4 months•do not take for more than 14 days or more often than every 4 months unless directed by a doctor•children under 18 years of age: ask a doctor. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Meijer Distribution Inc, this product is identified by NDC 41250-938 and is authorized under FDA application ANDA201361.
Identification & Billing
- RxCUI: 616539 - omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule
- RxCUI: 616539 - Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule
Clinical Specifications
- Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
- Proton Pump Inhibitors - [MoA] (Mechanism of Action)
Regulatory & Marketing
Hierarchy Structure
- 41250 - Meijer Distribution Inc
- 41250-938 - Omeprazole And Sodium Bicarbonate
- 41250-938-03 - 3 BOTTLE in 1 CARTON / 14 CAPSULE, GELATIN COATED in 1 BOTTLE (41250-938-01)
- 41250-938 - Omeprazole And Sodium Bicarbonate
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 41250-938-03 identifies a specific commercial package of 3 bottle in 1 carton / 14 capsule, gelatin coated in 1 bottle (41250-938-01) of Omeprazole And Sodium Bicarbonate, a human over the counter drug labeled by Meijer Distribution Inc. This capsule, gelatin coated is formulated for oral use and contains omeprazole; sodium bicarbonate as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Meijer Distribution Inc on April 03, 2020. The current certification is valid through December 31, 2026.
How is this Meijer Distribution Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 41250093803. 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.