NDC 65841-135 Famotidine

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
65841-135
Proprietary Name:
Famotidine
Non-Proprietary Name: [1]
Famotidine
Substance Name: [2]
Famotidine
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler Name: [5]
Cadila Healthcare Limited
Labeler Code:
65841
Marketing Category: [8]
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date: [9]
12-13-2021
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Navigator:

Product Packages

NDC Code 65841-135-05

Package Description: 1 BAG in 1 DRUM / 1 BAG in 1 BAG / 1 BAG in 1 BAG / 25 kg in 1 BAG

NDC Code 65841-135-06

Package Description: 1 BAG in 1 DRUM / 1 BAG in 1 BAG / 1 BAG in 1 BAG / 30 kg in 1 BAG

NDC Code 65841-135-12

Package Description: 1 BAG in 1 DRUM / 1 BAG in 1 BAG / 1 BAG in 1 BAG / 20 kg in 1 BAG

Product Details

What is NDC 65841-135?

The NDC code 65841-135 is assigned by the FDA to the UNFINISHED product Famotidine which is a bulk ingredient product labeled by Cadila Healthcare Limited. The generic name of Famotidine is famotidine. The product's dosage form is powder. The product is distributed in 3 packages with assigned NDC codes 65841-135-05 1 bag in 1 drum / 1 bag in 1 bag / 1 bag in 1 bag / 25 kg in 1 bag, 65841-135-06 1 bag in 1 drum / 1 bag in 1 bag / 1 bag in 1 bag / 30 kg in 1 bag, 65841-135-12 1 bag in 1 drum / 1 bag in 1 bag / 1 bag in 1 bag / 20 kg in 1 bag. 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 Famotidine?

Famotidine is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Famotidine belongs to a class of drugs known as H2 blockers. This medication is also available without a prescription. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.

What are Famotidine Active Ingredients?

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 1 kg/kg - A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.

* Please review the disclaimer below.

Product Footnotes

[1] 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.

[2] 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.

[3] 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.

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

[8] 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.

[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".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.