Acid Reducer Tablet
NDC 43598-960

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 43598-960?
  5. Acid Reducer Maximum Strength Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Acid Reducer (famotidine) is a ANDA-approved product labeled by Dr.reddys Laboratories Inc.. Ranitidine is known as an H2 blocker. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 43598-960 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
43598-960
Proprietary Name:
Acid Reducer Maximum Strength
Non-Proprietary Name: [1]
Famotidine
Substance Name: [2]
Famotidine
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Dr.reddys Laboratories Inc.
Labeler Code:
43598
Product Label ID:
ca039876-f7e5-3e60-da5a-a1f40637a417
FDA Application Number: [6]
ANDA077367
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-01-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
6 MM
8 MM
Imprint(s):
C;118
L1
Score:
1

Code Structure Chart

Product Details

What is NDC 43598-960?

The NDC code 43598-960 is assigned by the FDA to the product Acid Reducer Maximum Strength. It is commonly known by its generic name, famotidine. This pharmaceutical product is labeled by Dr.reddys Laboratories Inc. and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 43598-960-32, 43598-960-65, 43598-960-91. 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?

Ranitidine is known as an H2 blocker. It works by reducing the amount of acid in your stomach. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). This drug has been withdrawn from the US market due to problems with safety. A possible cancer-causing impurity has been found in some ranitidine products.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • FAMOTIDINE 20 mg/1 - A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Famotidine


Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".