Ranitidine

Ranitidine

Ranitidine Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Ranitidine Tablets, USP are indicated in:

  1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
  2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
  3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
  4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
  5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
  6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets, USP 150 mg b.i.d.
  7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets, USP 150 mg q.i.d.
  8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

 

History

There is currently no drug history available for this drug.

Other Information

The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine Tablets, USP 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:

MM1

The empirical formula is C13H22N4O3S·HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor.

Each Ranitidine Tablets, USP 150 mg for oral administration contains 167.4 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and FD&C Yellow #6.

Each Ranitidine Tablets, USP 300 mg for oral administration contains 334.8 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and D&C Yellow #10.

 

Ranitidine Manufacturers


  • Remedyrepack Inc.
    Ranitidine Tablet [Remedyrepack Inc. ]
  • American Health Packaging
    Ranitidine Tablet, Film Coated [American Health Packaging]
  • Supervalu Inc.
    Ranitidine (Ranitidine Hydrochloride) Tablet, Film Coated [Supervalu Inc.]
  • Blenheim Pharmacal, Inc.
    Ranitidine Tablet [Blenheim Pharmacal, Inc.]
  • Blenheim Pharmacal, Inc.
    Ranitidine Tablet [Blenheim Pharmacal, Inc.]
  • Remedyrepack Inc.
    Ranitidine Tablet, Film Coated [Remedyrepack Inc. ]
  • Direct Rx
    Ranitidine Tablet [Direct Rx]
  • Blenheim Pharmacal, Inc.
    Ranitidine Tablet, Film Coated [Blenheim Pharmacal, Inc.]
  • Dr. Reddy’s Laboratories Limited
    Ranitidine (Ranitidine Hydrochloride) Tablet, Film Coated [Dr. Reddy’s Laboratories Limited]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
    Ranitidine Tablet [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
  • Amneal Pharmaceuticals
    Ranitidine Tablet [Amneal Pharmaceuticals]
  • Rebel Distributors
    Ranitidine (Ranitidine) Tablet [Rebel Distributors]
  • Contract Pharmacy Services-pa
    Ranitidine Tablet [Contract Pharmacy Services-pa]
  • Wockhardt Usa Llc.
    Ranitidine Tablet, Coated [Wockhardt Usa Llc.]
  • Wockhardt Usa Llc.
    Ranitidine Tablet, Coated [Wockhardt Usa Llc.]
  • State Of Florida Doh Central Pharmacy
    Ranitidine Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Ranitidine Tablet [State Of Florida Doh Central Pharmacy]
  • Contract Pharmacy Services-pa
    Ranitidine Tablet [Contract Pharmacy Services-pa]
  • State Of Florida Doh Central Pharmacy
    Ranitidine Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • Wockhardt Limited
    Ranitidine Tablet [Wockhardt Limited]
  • Wockhardt Usa Llc
    Ranitidine Tablet [Wockhardt Usa Llc]
  • Major Pharmaceuticals
    Ranitidine Tablet [Major Pharmaceuticals]
  • Cardinal Health
    Ranitidine Tablet, Film Coated [Cardinal Health]
  • Remedyrepack Inc.
    Ranitidine (Ranitidine) Tablet [Remedyrepack Inc. ]
  • Glenmark Generics Inc., Usa
    Ranitidine Tablet, Film Coated [Glenmark Generics Inc., Usa]
  • Bryant Ranch Prepack
    Ranitidine Tablet [Bryant Ranch Prepack]
  • Physicians Total Care, Inc.
    Ranitidine Tablet [Physicians Total Care, Inc.]
  • Shasun Pharmaceuticals Limited
    Ranitidine Tablet [Shasun Pharmaceuticals Limited]
  • Wockhardt Limited
    Ranitidine Tablet, Coated [Wockhardt Limited]
  • Wockhardt Limited
    Ranitidine Tablet, Coated [Wockhardt Limited]
  • Wockhardt Limited
    Ranitidine (Ranitidine Hydrochloride) Syrup [Wockhardt Limited]
  • Wockhardt Usa Llc
    Ranitidine (Ranitidine Hydrochloride) Syrup [Wockhardt Usa Llc]
  • Preferred Pharmaceuticals, Inc
    Ranitidine Tablet [Preferred Pharmaceuticals, Inc]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Ranitidine Tablet, Film Coated [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Cardinal Health
    Ranitidine Tablet [Cardinal Health]
  • American Health Packaging
    Ranitidine (Ranitidine Hydrochloride) Tablet [American Health Packaging]
  • Shasun Pharmaceuticals Limited
    Ranitidine Tablet [Shasun Pharmaceuticals Limited]
  • Stat Rx Usa Llc
    Ranitidine Tablet [Stat Rx Usa Llc]
  • Mckesson Contract Packaging
    Ranitidine Tablet, Film Coated [Mckesson Contract Packaging]
  • Pd-rx Pharmaceuticals, Inc.
    Ranitidine Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Physicians Total Care, Inc.
    Ranitidine (Ranitidine Hydrochloride) Solution [Physicians Total Care, Inc.]
  • Unit Dose Services
    Ranitidine Tablet, Film Coated [Unit Dose Services]
  • Cardinal Health
    Ranitidine Tablet [Cardinal Health]
  • Ivax Pharmaceuticals, Inc.
    Ranitidine Tablet, Film Coated [Ivax Pharmaceuticals, Inc.]
  • Shopko Stores Operating Co., Llc.
    Ranitidine Tablet [Shopko Stores Operating Co., Llc.]
  • Chain Drug Marketing Association Inc.
    Ranitidine (Ranitidine Hydrochloride) Tablet, Film Coated [Chain Drug Marketing Association Inc.]
  • Stat Rx Usa Llc
    Ranitidine Tablet [Stat Rx Usa Llc]
  • Aidarex Pharmaceuticals Llc
    Ranitidine Tablet [Aidarex Pharmaceuticals Llc]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
    Ranitidine Tablet [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
  • Pd-rx Pharmaceuticals, Inc.
    Ranitidine Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Ranitidine Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Wockhardt Usa Llc.
    Ranitidine (Ranitidine Hydrochloride) Tablet [Wockhardt Usa Llc.]
  • Wockhardt Limited
    Ranitidine (Ranitidine Hydrochloride) Tablet [Wockhardt Limited]
  • Lake Erie Medical Dba Quality Care Products Llc
    Ranitidine Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Valu Merchandisers Company
    Ranitidine (Ranitidine Hydrochloride) Tablet, Film Coated [Valu Merchandisers Company]
  • Wal-mart Stores, Inc
    Ranitidine (Ranitidine Hydrochloride) Tablet, Film Coated [Wal-mart Stores, Inc]
  • Shopko Stores Operating Co., Llc
    Ranitidine Tablet [Shopko Stores Operating Co., Llc]
  • Remedyrepack Inc.
    Ranitidine Tablet, Film Coated [Remedyrepack Inc. ]
  • Medline Industries, Inc.
    Ranitidine Tablet [Medline Industries, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Ranitidine Tablet [Pd-rx Pharmaceuticals, Inc.]
  • P And L Development Of New York Corporation
    Ranitidine Tablet [P And L Development Of New York Corporation]
  • Cardinal Health
    Ranitidine Tablet, Film Coated [Cardinal Health]
  • Remedyrepack Inc.
    Ranitidine Tablet, Film Coated [Remedyrepack Inc. ]
  • Unit Dose Services
    Ranitidine Tablet, Film Coated [Unit Dose Services]
  • Dr. Reddy’s Laboratories Limited
    Ranitidine Tablet [Dr. Reddy’s Laboratories Limited]
  • Apotex Corp.
    Ranitidine (Ranitidine Hydrochloride) Tablet, Film Coated [Apotex Corp.]
  • Clinical Solutions Wholesale
    Ranitidine Tablet [Clinical Solutions Wholesale]
  • Medvantx, Inc.
    Ranitidine Tablet, Film Coated [Medvantx, Inc.]
  • Fred’s Inc.
    Ranitidine Tablet, Film Coated [Fred’s Inc.]
  • Amerisource Bergen
    Ranitidine Tablet, Film Coated [Amerisource Bergen]
  • Remedyrepack Inc.
    Ranitidine Tablet, Film Coated [Remedyrepack Inc. ]
  • Sunmark
    Ranitidine Tablet, Film Coated [Sunmark]
  • Health Mart
    Ranitidine Tablet, Film Coated [Health Mart]
  • Cardinal Health
    Ranitidine Tablet, Film Coated [Cardinal Health]
  • Cvs Pharmacy, Inc
    Ranitidine Tablet, Film Coated [Cvs Pharmacy, Inc]
  • Major Pharmaceuticals
    Ranitidine Tablet, Film Coated [Major Pharmaceuticals]
  • Clinical Solutions Wholesale
    Ranitidine Tablet, Film Coated [Clinical Solutions Wholesale]
  • Walgreen Company
    Ranitidine Tablet, Film Coated [Walgreen Company]
  • Liberty Pharmaceuticals, Inc.
    Ranitidine Tablet [Liberty Pharmaceuticals, Inc.]
  • Liberty Pharmaceuticals, Inc.
    Ranitidine (Ranitidine Hydrochloride) Tablet, Film Coated [Liberty Pharmaceuticals, Inc.]
  • St Marys Medical Park Pharmacy
    Ranitidine Tablet [St Marys Medical Park Pharmacy]
  • Cardinal Health
    Ranitidine Tablet [Cardinal Health]
  • Silarx Pharmaceuticals, Inc
    Ranitidine (Ranitidine Hydrochloride) Solution [Silarx Pharmaceuticals, Inc]
  • Carilion Materials Management
    Ranitidine Tablet [Carilion Materials Management]
  • American Health Packaging
    Ranitidine Tablet [American Health Packaging]
  • Apotex Corp.
    Ranitidine (Ranitidine Hydrochloride) Tablet, Film Coated [Apotex Corp.]
  • Clinical Solutions Wholesale
    Ranitidine Tablet, Film Coated [Clinical Solutions Wholesale]
  • Aurobindo Pharma Limited
    Ranitidine (Ranitidine Hydrochloride) Syrup [Aurobindo Pharma Limited]
  • Avkare, Inc.
    Ranitidine Tablet [Avkare, Inc.]
  • Northwind Pharmaceuticals, Llc
    Ranitidine (Ranitidine Hydrochloride) Tablet [Northwind Pharmaceuticals, Llc]
  • Par Pharmaceutical Inc
    Ranitidine Tablet [Par Pharmaceutical Inc]
  • Proficient Rx Lp
    Ranitidine Tablet, Film Coated [Proficient Rx Lp]
  • Medsource Pharmaceuticals
    Ranitidine Tablet [Medsource Pharmaceuticals]

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