Ranitidine 150 mg/1
Ranitidine · TABLET · Amneal Pharmaceuticals of New York LLC
Ranitidine is a tablet containing ranitidine at 150 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.
Key Facts
- Brand Name
- Ranitidine
- Generic Name
- Ranitidine
- NDC Code (Product)
53746-253- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- Strength
- 150 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077824
- Marketing Start
- 12/16/2009
Recall History
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of NDMA impurity detected in product.
Mckesson Packaging Services
Failed Stability Specifications
Dr. Reddy's Laboratories, Inc.
CGMP Deviations: Presence of NDMA impurity detected in product.
Novitium Pharma LLC
CGMP Deviations: Presence of NDMA impurity detected in product.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of NDMA impurity detected in product.
Perrigo Company PLC
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Precision Dose Inc.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Granules India Limited
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Sandoz, Inc
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Preferred Pharmaceuticals, Inc
CGMP Deviations: Presence of NDMA impurity detected in product.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use(s) 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
Dosage & Administration
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
Warnings
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 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 kidney disease Ask a doctor or pharmacist before use if you are • taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask 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).
Frequently Asked Questions
What is Ranitidine used for?
Ranitidine contains Ranitidine. It is a tablet taken oral. Consult your doctor for specific uses.
Is Ranitidine a controlled substance?
Ranitidine is not classified as a controlled substance by the DEA.
What is the generic name for Ranitidine?
The generic name for Ranitidine is Ranitidine. There are 6 other brand versions of Ranitidine.
What is the NDC code for Ranitidine 150 mg/1?
The NDC (National Drug Code) for Ranitidine 150 mg/1 is 53746-253, listed by Amneal Pharmaceuticals of New York LLC.