Rabeprazole Sodium
NDC 50436-0302
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Rabeprazole Sodium is a ANDA-approved product labeled by Unit Dose Services. Rabeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It is supplied as a blue product. This product entry covers the primary NDC 50436-0302 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
50436-0302
Proprietary Name:
Rabeprazole Sodium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
50436
Product Label ID:
FDA Application Number: [6]
ANDA090678
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
11-08-2013
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Product Characteristics
Color(s):
BLUE (C48333)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
KU;7
Score:
1
Code Structure Chart
Product Details
What is NDC 50436-0302?
The NDC code 50436-0302 is assigned by the FDA to the product Rabeprazole Sodium. This pharmaceutical product is labeled by Unit Dose Services and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50436-0302-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Rabeprazole 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. Rabeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- RABEPRAZOLE SODIUM (UNII: 3L36P16U4R)
- RABEPRAZOLE (UNII: 32828355LL) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
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: 854868 - RABEprazole sodium 20 MG Delayed Release Oral Tablet
- RxCUI: 854868 - rabeprazole sodium 20 MG Delayed Release Oral Tablet
* Please review the full disclaimer at the bottom of this page.
Patient Education
Rabeprazole
Rabeprazole is used 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 that connects the throat and stomach) in adults and children 12 year of age and older. Rabeprazole is used to treat damage from GERD, allow the esophagus to heal, and prevent further damage to the esophagus in adults. Rabeprazole is also used to treat conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome in adults. Rabeprazole is used to treat ulcers (sores in the lining of the stomach or intestine) and is used in combination with other medications to eliminate H. pylori (a bacteria that causes ulcers) in adults. Rabeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
