NDC 69336-112 Not Applicable

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
69336-112
Proprietary Name:
Not Applicable
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Sterling Knight Pharmaceuticals Llc
Labeler Code:
69336
Start Marketing Date: [9]
07-13-2017
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WIHTE)
Shape:
CAPSULE (C48336)
Size(s):
30 MM
Imprint(s):
SG;363
Score:
1

Product Packages

NDC Code 69336-112-30

Package Description: 30 CAPSULE in 1 PACKAGE

Product Details

What is NDC 69336-112?

The NDC code 69336-112 is assigned by the FDA to the product Not Applicable which is product labeled by Sterling Knight Pharmaceuticals Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69336-112-30 30 capsule in 1 package . 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 Not Applicable?

Omeprazole and sodium bicarbonate is a proton pump inhibitor indicated for:Short-term treatment of active duodenal ulcer (1.1)Short-term treatment of active benign gastric ulcer (1.2)Treatment of gastroesophageal reflux disease (GERD) (1.3)Maintenance of healing of erosive esophagitis (1.4)The safety and effectiveness of omeprazole and sodium bicarbonate capsules in pediatric patients (<18 years of age) have not been established. (8.4)

Which are Not Applicable UNII Codes?

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

Which are Not Applicable 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 Not Applicable?

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: 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".