NDC 49348-817 Sunmark Acid Reducer Maximum Strength
Famotidine Tablet, Film Coated Oral

Product Information

What is NDC 49348-817?

The NDC code 49348-817 is assigned by the FDA to the product Sunmark Acid Reducer Maximum Strength which is a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Sunmark Acid Reducer Maximum Strength is famotidine. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 49348-817-05 25 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack, 49348-817-09 1 bottle in 1 carton / 50 tablet, film coated 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, RxNorm crosswalk and the complete product label.

NDC Product Code49348-817
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Sunmark Acid Reducer Maximum Strength
Non-Proprietary Name 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.
Famotidine
Product Type 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.
Human Otc Drug
Dosage FormTablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Strategic Sourcing Services Llc
Labeler Code49348
FDA Application Number 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.
ANDA077351
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-18-2007
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Sunmark Acid Reducer Maximum Strength?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)8 MM
Imprint(s)L194
Score1

Product Packages

NDC Code 49348-817-05

Package Description: 25 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK

Price per Unit: $0.15386 per EA

NDC Code 49348-817-09

Package Description: 1 BOTTLE in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.15386 per EA

Product Details

What are Sunmark Acid Reducer Maximum Strength 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 20 mg/1 - A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.

Sunmark Acid Reducer Maximum Strength Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? 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 code indicates a single concept unique identifier (RXCUI) is associated with this product:

Sunmark Acid Reducer Maximum Strength 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.

Pharmacologic Class(es)

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

Famotidine is pronounced as (fa moe' ti deen)

Why is famotidine medication prescribed?
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 backw...
[Read More]

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Sunmark Acid Reducer Maximum Strength Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient (In Each Tablet)



Famotidine 20 mg


Purpose



Acid reducer


Uses



  • •relieves heartburn associated with acid indigestion and sour stomach
  • •prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings



Allergy alert: Do not use if you are allergic to famotidine or other acid reducers


Do Not Use



  • •if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • •if you have kidney disease, except under the advice and supervision of a doctor
  • •with other acid reducers

Ask A Doctor Before Use If You Have



  • •had heartburn over 3 months. This may be a sign of a more serious condition.
  • •heartburn with lightheadedness, sweating, or dizziness
  • •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • •frequent chest pain
  • •frequent wheezing, particularly with heartburn
  • •unexplained weight loss
  • •nausea or vomiting
  • •stomach pain

Stop Use And Ask A Doctor If



  • •your heartburn continues or worsens
  • •you need to take this product for more than 14 days

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • •adults and children 12 years and over:
  • •to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
  • •to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
  • •do not use more than 2 tablets in 24 hours
  • •children under 12 years: ask a doctor

Other Information



  • •read the directions and warnings before use
  • •keep the carton. It contains important information.
  • •store at 20°-25°C (68°-77°F)
  • •protect from moisture and light

Inactive Ingredients



carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to Maximum Strength Pepcid® AC active ingredient

Maximum Strength

Acid Reducer

Famotidine Tablets USP, 20 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Just One Per Dose

Actual Size

25 TABLETS

Acid Reducer Carton

Acid Reducer Carton


* Please review the disclaimer below.