NDC 0904-6716 Ranitidine

Ranitidine

NDC Product Code 0904-6716

NDC Code: 0904-6716

Proprietary Name: Ranitidine 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.

Non-Proprietary Name: Ranitidine 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.

Product Characteristics

Color(s):
BROWN (C48332 - PINKISH)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
L852
Score: 1

NDC Code Structure

NDC 0904-6716-24

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET, FILM COATED in 1 BOTTLE

NDC 0904-6716-51

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

NDC Product Information

Ranitidine with NDC 0904-6716 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Ranitidine is ranitidine. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Tablet, 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.

Product Type: Human Otc Drug 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.

Ranitidine Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • RANITIDINE HYDROCHLORIDE 150 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)

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.

Labeler Name: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: ANDA091429 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 08-07-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Ranitidine

Ranitidine is pronounced as (ra ni' ti deen)

Why is ranitidine medication prescribed?
Ranitidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the...
[Read More]

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Ranitidine Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 168 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 foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine 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. •with other acid reducers •if you have kidney disease, except under the advice and supervision of a doctor

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 (1-800-222-1222).

Directions

  • •adults and children 12 years and over: •to relieve symptoms, swallow 1 tablet with a glass of water •to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn •can be used up to twice daily (do not take more than 2 tablets in 24 hours) •children under 12 years: ask a doctor

Other Information

  • •do not use if printed foil under bottle cap is open or torn •store at 20°-25°C (68°-77°F) •avoid excessive heat or humidity •this product is sodium and sugar free

Inactive Ingredients

D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin

Consumer Information

  • What you should know about MAXIMUM STRENGTHRanitidine Tablets, 150 mgAcid Reducer(Please read all of this information before taking MAXIMUM STRENGTH Ranitidine Tablets, 150 mg. Save this leaflet for future reference.)What are MAXIMUM STRENGTH Ranitidine Tablets, 150 mg? • MAXIMUM STRENGTH Ranitidine Tablets, 150 mg contain 150 mg of ranitidine (as ranitidine hydrochloride, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide.Excellent Safety Record •The ingredient in MAXIMUM STRENGTH Ranitidine Tablets, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets, 150 mg has been taken safely with many frequently prescribed medications. •MAXIMUM STRENGTH Ranitidine Tablets, 150 mg are sodium and sugar free.What symptoms do MAXIMUM STRENGTH Ranitidine Tablets, 150 mg relieve and prevent? •MAXIMUM STRENGTH Ranitidine Tablets, 150 mg relieve and prevent heartburn associated with acid indigestion and sour stomach. •Certain foods or beverages, and even lying down to sleep can cause heartburn associated with acid indigestion and sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.How should I take MAXIMUM STRENGTH Ranitidine Tablets, 150 mg? •To relieve symptoms, swallow 1 tablet with a glass of water. •To prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn. •This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours). •MAXIMUM STRENGTH Ranitidine Tablets, 150 mg should not be given to children under 12 years old unless directed by a doctor. •Allergy alert: Do not use if you are allergic to ranitidine or other acid reducersHow do MAXIMUM STRENGTH Ranitidine Tablets, 150 mg work? •MAXIMUM STRENGTH Ranitidine Tablets, 150 mg reduce the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets, 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.Tips for managing heartburn •Do not lie flat or bend over soon after eating •Do not eat late at night, or just before bedtime •Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables. •Eat slowly and do not eat big meals •If you are overweight, lose weight •If you smoke, quit smoking •Raise the head of your bed •Wear loose fitting clothing around your stomachWhen should I see a doctor? •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. •with other acid reducers •if you have kidney disease, except under the advice and supervision of a doctor •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 healthcare professional before use. •Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).Questions or comments? 1-800-719-9260BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn.BLISTERS: Do not use if the individual blister unit is open or torn.Distributed byPerrigo®Allegan, MI 49010: 852B4 00 J2

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