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  4. NDC Product Code: 13107-115 Omeprazole And Sodium Bicarbonate

NDC 13107-115 Omeprazole And Sodium Bicarbonate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 13107-115?
  5. Omeprazole And Sodium Bicarbonate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
13107-115
Proprietary Name:
Omeprazole And Sodium Bicarbonate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aurolife Pharma, Llc
Labeler Code:
13107
Product Label ID:
1e3a3321-fd27-4b56-8690-933d0c8738b9
Start Marketing Date: [9]
09-30-2014
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT BLUE OPAQUE CAP)
WHITE (C48325 - WHITE OPAQUE BODY)
Shape:
CAPSULE (C48336)
Size(s):
23 MM
Imprint(s):
U;88
Score:
1

Product Packages

NDC Code 13107-115-05

Package Description: 500 CAPSULE in 1 BOTTLE

NDC Code 13107-115-30

Package Description: 30 CAPSULE in 1 BOTTLE

Price per Unit: $0.73047 per EA

Product Details

What is NDC 13107-115?

The NDC code 13107-115 is assigned by the FDA to the product Omeprazole And Sodium Bicarbonate which is product labeled by Aurolife Pharma, Llc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 13107-115-05 500 capsule in 1 bottle , 13107-115-30 30 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Omeprazole And Sodium Bicarbonate?

Omeprazole and sodium bicarbonate is contraindicated in patients with known hypersensitivity to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria. [See Adverse Reactions (6)]

Which are Omeprazole And Sodium Bicarbonate UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Omeprazole And Sodium Bicarbonate Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Omeprazole And Sodium Bicarbonate?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 616539 - omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule
  • RxCUI: 616539 - Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule
  • RxCUI: 616541 - omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule
  • RxCUI: 616541 - Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule

* Please review the disclaimer below.

Patient Education

Omeprazole


Prescription omeprazole is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
[Learn More]


Sodium Bicarbonate


Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic in certain conditions. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".