NDC 49348-473 Ranitidine

Product Information

Ranitidine is product labeled by Sunmark. The product's dosage form is and is administered via form.

Product Code49348-473
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.
Ranitidine
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Sunmark
Labeler Code49348
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.
09-20-2013
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.
12-31-2019
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".
I
NDC Code Structure

What are the uses for Ranitidine?


Product Characteristics

Color(s)PINK (C48328)
ShapeROUND (C48348)
Size(s)8 MM
Imprint(s)OR;606
Score1

Product Packages

NDC 49348-473-12

Package Description: 1 BOTTLE in 1 CARTON > 60 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.07894 per EA

NDC 49348-473-44

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.07057 per EA

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What are Ranitidine 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.
  • RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM)
  • RANITIDINE (UNII: 884KT10YB7) (Active Moiety)

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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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.
  • COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

* Please review the disclaimer below.

Patient Education

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]

* Please review the disclaimer below.

Ranitidine Labeling and Warnings

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.

Table of Contents



Active Ingredient (In Each Tablet)



Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 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

Ask A Doctor Before Use If You Have



  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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

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



  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER 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



Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide


Questions?



Call 1-800-406-7984


Principal Display Panel



sunmark®

*COMPARE TO ZANTAC 75® ACTIVE INGREDIENT

NDC 49348-473-12

Ranitidine Tablets, USP 75 mg

acid reducer

Prevents and Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Regular Strength

60 TABLETS

Distributed By McKesson

5104148/0713


* Please review the disclaimer below.