FAMOTIDINE 20 mg/1
Famotidine · TABLET · Ascent Pharmaceuticals, Inc.
Famotidine is an over-the-counter tablet that reduces stomach acid and is used to treat heartburn, acid reflux, and ulcers. It belongs to a class of medications called histamine-2 receptor antagonists, which work by decreasing the amount of acid your stomach produces.
Key Facts
- Brand Name
- FAMOTIDINE
- Generic Name
- Famotidine
- NDC Code (Product)
43602-602- Manufacturer
- Ascent Pharmaceuticals, Inc.
- Strength
- 20 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216030
- Drug Class
- Histamine-2 Receptor Antagonist [EPC]
- Marketing Start
- 11/03/2021
Recall History
Aidapak Services, LLC
Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500
Novel Laboratories, Inc.
Failed Impurity/Degradation Specification; 12-month stability time point
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Lupin Pharmaceuticals Inc.
CGMP Deviations
Glenmark Therapeutics, Inc.
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
PD-Rx Pharmaceuticals, Inc.
Failed Tablet/Capsule Specification: out of specification for tablet weight.
Fresenius Kabi USA, LLC
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
HF Acquisition Co. LLC
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Aurobindo Pharma USA Inc.
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer (GU). • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of duodenal ulcer recurrence. Famotidine tablets are a histamine-2 (H 2 ) receptor antagonist indicated ( 1 ): In adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer. • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. In adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of DU recurrence.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Indication Recommended Dosage ( 2.1 ) Adult and Pediatric Patients 40 kg and greater Active DU 40 mg once daily; or 20 mg twice daily Active Gastric Ulcer 40 mg once daily GERD 20 mg twice daily Erosive Esophagitis 20 mg twice daily; or 40 mg twice daily Adults Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Recurrence 20 mg once daily • See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration. ( 2.1 , 2.2 ) Administration ( 2.3 ): • Take once daily before bedtime or twice daily in the morning and before bedtime with or without food. 2.1 Recommended Dosage Table 1 shows the recommended dosage of famotidine 20 mg and 40 mg tablets in adult and pediatric patients weighing 40 kg and greater with normal renal function. The use of famotidine 20 mg and 40 mg tablets is not recommended in pediatric patients weighing less than 40 kg because the lowest available strength (20 mg) exceeds the recommended dose for these patients. Use another famotidine formulation for pediatric patients weighing less…
Contraindications
4 CONTRAINDICATIONS Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 receptor antagonists. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Drugs Dependent on Gastric pH for Absorption: Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. See full prescribing information for a list of interacting drugs. ( 7.1 ) • Tizanidine (CYP1A2) Substrate: Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness; avoid concomitant use, if possible. ( 7.2 ) 7.1 Drugs Dependent on Gastric pH for Absorption Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity, leading to loss of efficacy of the concomitant drug. Concomitant administration of famotidine with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended. See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine. 7.2 Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentration…
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Famotidine was studied in 7 US and international placebo- and active-controlled trials in approximately 2500 patients [see Clinical Studies ( 14 )]. A total of 1442 patients were treated with famotidine, including 302 treated with 40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily. The population was 17 to 91 years old, fairly well distributed between gender and race; however, the predominant race treated was Caucasian. The following adverse reactions occurred in greater than or equal to 1% of famotidine-treated patients: headache, dizziness and constipation. Th…
Frequently Asked Questions
What is FAMOTIDINE used for?
Famotidine is an over-the-counter tablet that reduces stomach acid and is used to treat heartburn, acid reflux, and ulcers. It belongs to a class of medications called histamine-2 receptor antagonists, which work by decreasing the amount of acid your stomach produces.
Is FAMOTIDINE a controlled substance?
FAMOTIDINE is not classified as a controlled substance by the DEA.
What is the generic name for FAMOTIDINE?
The generic name for FAMOTIDINE is Famotidine. There are 10 other brand versions of Famotidine.
What is the NDC code for FAMOTIDINE 20 mg/1?
The NDC (National Drug Code) for FAMOTIDINE 20 mg/1 is 43602-602, listed by Ascent Pharmaceuticals, Inc..
Other FAMOTIDINE Dosages
Other Famotidine Brands
See all →- Famotidine20 mg/172205-145
- AMAZON BASIC CARE ACID REDUCER20 mg/172288-363
- topcare acid reducer20 mg/176162-300
- Famotidine20 mg/10615-8558
- Maximum Strength Acid Reducer20 mg/111673-697
- Signature Care Acid Reducer Complete800 mg/121130-087
- acid controller20 mg/121130-521
- injoy heartburn relief800 mg/10113-6023
- Dual Action Complete800 mg/137808-503
- Dual Action Complete800 mg/141250-690
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)