Famotidine 20 mg Tablet, Film Coated, 100-count
Other active recalls for Famotidine (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-2 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eat...
Read the full MedlinePlus article ↗- Great question. Antacids (like Tums) neutralize acid that's already in your stomach — they work fast but don't last long. Famotidine is different: it actually blocks a signal in yo...
- What exactly does famotidine do — and how is it different from antacids?
- The over-the-counter tablets are meant to relieve heartburn when it happens, or to prevent it if you take them 10 to 60 minutes before a meal that usually causes trouble. You shoul...
- Can I take the OTC version whenever I have heartburn, or is there a limit?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Famotidine — tap one for details:
Famotidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII SA1B764746
A synthetic polymer commonly used as a solvent and binder in medicines. It helps dissolve active ingredients, improve texture, and ensure consistent tablet or capsule formation.
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UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.029 | $2.86 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1869 | $18.69 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.0827 | $8.27 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Famotidine 20 mgthis 00172-5728-60 | Teva | 100 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 00904-7193-06 | Major | 1 tablet | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 31722-0017-01 | Camber | 100 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 50268-0299-15 | AvPAK | 1 tablet | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 55111-0119-01 | Dr.Reddy's | 100 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 60687-0595-01 | American | 1 tablet | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 61442-0121-01 | Carlsbad | 2400 tablets | $0.029 | AB | Availability likely | — |
| famotidine 20 mg 62135-0807-90 | Chartwell | 90 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 64980-0623-01 | Rising | 100 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 65862-0859-01 | Aurobindo | 100 tablets | $0.029 | — | Availability likely | — |
| Famotidine 20 mg 67877-0842-01 | Ascend | 100 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 68001-0397-00 | BluePoint | 100 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 68645-0594-59 | Legacy | 60 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 69367-0400-10 | Westminster | 1000 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 70710-1683-00 | Zydus | 1000 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 70756-0051-11 | Lifestar | 100 tablets | $0.029 | AB | Availability likely | — |
| Famotidine 20 mg 72205-0145-05 | Novadoz | 500 tablets | $0.029 | AB | Availability likely | — |
| Good Sense Acid Reducer 20 mg 00113-0194-02 | L. | 1 tablet | $0.143 | — | Availability likely | +398% |
| Rugby Famotidine 20 mg 00536-1298-01 | Rugby | 100 tablets | $0.143 | — | Availability likely | +398% |
| Major Heartburn Relief Maximum Strength 20 mg 00904-5780-17 | Major | 1 tablet | $0.143 | — | Availability likely | +398% |
| Famotidine 20 mg 46122-0737-63 | Amerisource | 25 tablets | $0.143 | — | Availability likely | +398% |
| Famotidine 20 mg 68094-0054-65 | Precision | 10 tablets | $0.143 | — | Availability likely | +398% |
| famotidine 20 mg 69230-0327-01 | Camber | 100 tablets | $0.143 | — | Availability likely | +398% |
| Famotidine 20 mg 70000-0049-01 | LEADER/ | 25 tablets | $0.143 | — | Availability likely | +398% |
| Leader Acid Reducer 20 mg 70000-0654-01 | Cardinal | 50 tablets | $0.143 | — | Availability likely | +398% |
| Famotidine 20 mg 70000-0710-01 | LEADER/ | 200 tablets | $0.143 | — | Availability likely | +398% |
| foster and thrive acid reducer 20 mg 70677-1101-01 | Strategic | 1 tablet | $0.143 | — | Availability likely | +398% |
| famotidine 20 mg 83324-0008-50 | CHAIN | 50 tablets | $0.143 | — | Availability likely | +398% |
| Famotidine 20 mg 83324-0116-25 | Chain | 25 tablets | $0.143 | — | Availability likely | +398% |
| Pepcid 20 mg 00187-4420-10 | Bausch | 100 tablets | — | AB | FDA listed | — |
| Acid Controller 20 mg 00363-0701-01 | Walgreen | 85 tablets | — | — | Discontinued | — |
| acid controller 20 mg 00363-1203-71 | Walgreen | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 00363-1899-14 | WALGREEN | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 00363-5300-14 | WALGREEN | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 00615-8558-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 10267-5689-01 | Contract | 100 tablets | — | AB | FDA listed | — |
| Maximum Strength Acid Reducer 20 mg 11673-0697-01 | TARGET | 100 tablets | — | — | FDA listed | — |
| acid relief 20 mg 11822-1014-00 | Rite | 50 tablets | — | — | FDA listed | — |
| acid relief 20 mg 11822-1194-01 | Rite | 50 tablets | — | — | FDA listed | — |
| acid relief 20 mg 11822-6123-00 | Rite | 50 tablets | — | — | FDA listed | — |
| PEPCID AC Maximum Strength 20 mg 16837-0855-05 | Kenvue | 5 tablets | — | — | Discontinued | — |
| Maximum Strength PEPCID AC Icy Cool Mint 20 mg 16837-0889-20 | Kenvue | 20 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 21130-0023-25 | Albertsons | 25 tablets | — | — | FDA listed | — |
| Maximum Strength Acid Controller 20 mg 21130-0027-05 | BETTER | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 21130-0033-14 | Better | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 21130-0191-20 | SAFEWAY | 200 tablets | — | — | FDA listed | — |
| acid controller 20 mg 21130-0521-82 | Safeway | 200 tablets | — | — | FDA listed | — |
| Signature Care Acid Controller maximum strength 20 mg 21130-0777-02 | Safeway | 1 tablet | — | — | Discontinued | — |
| Famotidine 20 mg 25000-0087-03 | MARKSANS | 30 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 25000-0124-68 | MARKSANS | 300 tablets | — | — | FDA listed | — |
| heartburn prevention 20 mg 30142-0194-71 | Kroger | 50 tablets | — | — | FDA listed | — |
| TopCare Acid Reducer 20 mg 36800-0194-02 | Topco | 1 tablet | — | — | FDA listed | — |
| Acid Controller 20 mg 37808-0042-63 | H | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 37835-0165-50 | Bi-Mart | 50 tablets | — | — | FDA listed | — |
| equaline heartburn prevention 20 mg 41163-0001-02 | United | 1 tablet | — | — | FDA listed | — |
| Zantac 360 20 mg 41167-0361-00 | Chattem, | 8 tablets | — | — | FDA listed | — |
| Zantac 360 Cool Mint 20 mg 41167-0364-01 | Chattem, | 50 tablets | — | — | Discontinued | — |
| heartburn relief 20 mg 41250-0712-02 | Meijer | 1 tablet | — | — | FDA listed | — |
| CareOne Acid Relief 20 mg 41520-0707-02 | American | 1 tablet | — | — | Discontinued | — |
| Acid Reducer 20 mg 42507-0194-01 | HyVee | 1 tablet | — | — | FDA listed | — |
| Famotidine 20 mg 43063-0695-20 | PD-Rx | 20 tablets | — | AB | FDA listed | — |
| Acid Reducer Maximum Strength 20 mg 43598-0960-32 | Dr.Reddys | 170 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 43602-0602-03 | Ascent | 300 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 46708-0293-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 48433-0150-20 | Safecor | 1 tablet | — | AB | FDA listed | — |
| Famotidine 20 mg 49035-0505-14 | Wal-Mart | 50 tablets | — | — | FDA listed | — |
| Equate Famotidine 20 mg 49035-0650-71 | Wal-Mart | 50 tablets | — | — | FDA listed | — |
| Maximum Strength Acid Reducer 20 mg 49483-0720-20 | TIME | 200 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 50090-1044-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 50090-1045-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 50090-6582-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 50090-6932-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 50090-7178-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 50090-7180-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 50090-7829-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Zantac 360 1 per blister 6 blisters 20 mg 50269-0155-01 | JC | 1 tablet | — | — | FDA listed | — |
| Zantac 360 2 per blister 6 blisters 20 mg 50269-0156-01 | JC | 2 tablets | — | — | FDA listed | — |
| Acid Reducer 20 mg 51316-0511-63 | CVS | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 51407-0683-10 | Golden | 36000 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 51655-0233-25 | Northwind | 60 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 51655-0312-20 | Northwind | 20 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 53943-0101-25 | Discount | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 54257-0802-02 | Magno-Humphries, | 100 tablets | — | — | FDA listed | — |
| Calmicid AC Acid Reducer 20 mg 54473-0411-01 | Melaleuca, | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 55111-0396-08 | Dr.Reddys | 8 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 55154-2628-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Famotidine 20 mg 55154-4313-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Famotidine 20 mg 55315-0435-53 | Fred's, | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 55319-0057-10 | Family | 100 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 55319-0409-01 | FAMILY | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 55319-0427-10 | Family | 100 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 55681-0342-03 | TWIN | 300 tablets | — | — | FDA listed | — |
| dg health heartburn prevention 20 mg 55910-0194-02 | Dolgencorp | 1 tablet | — | — | FDA listed | — |
| dg health heartburn prevention 20 mg 55910-0665-71 | Dolgencorp | 50 tablets | — | — | FDA listed | — |
| dg health acid reducer 20 mg 55910-0814-71 | Dolgencorp | 50 tablets | — | — | FDA listed | — |
| Acid Reducer 20 mg 56062-0088-02 | Publix | 1 tablet | — | — | FDA listed | — |
| maximum strength 20 mg 56062-0194-02 | Publix | 1 tablet | — | — | FDA listed | — |
| Famotidine 20 mg 57896-0319-01 | Geri-Care | 100 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 58602-0706-14 | Aurohealth | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 58602-0829-21 | Aurohealth | 100 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 58602-0859-34 | Aurohealth | 200 tablets | — | — | FDA listed | — |
| Acid Controller 20 mg 59640-0001-63 | H | 25 tablets | — | — | FDA listed | — |
| acid reducer 20 mg 59640-0023-71 | H | 50 tablets | — | — | FDA listed | — |
| acid controller 20 mg 59779-0194-63 | CVS | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 62332-0001-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 63187-0129-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 63187-0723-00 | Proficient | 100 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 63629-7013-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 63868-0584-25 | Chain | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 63941-0011-53 | Best | 25 tablets | — | — | FDA listed | — |
| kirkland signature acid controller 20 mg 63981-0194-05 | Costco | 125 tablets | — | — | FDA listed | — |
| Zantac 360, Travel BASIX 20 mg 66715-6458-02 | Lil' | 2 tablets | — | — | FDA listed | — |
| Pepcid AC 20 mg 66715-9748-08 | Lil' | 1 tablet | — | — | FDA listed | — |
| Zantac 360 20 mg 66715-9758-05 | Lil' | 5 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 67296-2133-03 | Redpharm | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 67296-2186-03 | Redpharm | 30 tablets | — | AB | FDA listed | — |
| Zantac 360 20 mg 67751-0214-01 | Navajo | 1 tablet | — | — | FDA listed | — |
| Famotidine 20 mg 68016-0801-25 | Chain | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 68071-2306-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 68071-3201-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 68071-3420-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 68071-3786-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| members mark acid pep 20 mg 68196-0121-00 | Sam's | 100 tablets | — | — | FDA listed | — |
| berkley and jensen famotidine 20 mg 68391-0300-78 | BJWC | 100 tablets | — | — | Discontinued | — |
| Famotidine 20 mg 68788-4021-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 68788-4088-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 68788-4119-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 68788-8485-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 68788-8889-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Acid Reducer 20 mg 69168-0443-09 | Allegiant | 10 tablets | — | — | FDA listed | — |
| Acid Reducer 20 mg 69168-0445-32 | Allegiant | 100 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 69842-0087-14 | CVS | 50 tablets | — | — | FDA listed | — |
| acid reducer 20 mg 69842-0659-63 | CVS | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 69842-0924-14 | CVS | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 70518-3829-00 | REMEDYREPACK | 50 tablets | — | AB | Discontinued | — |
| Famotidine 20 mg 70518-4395-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 70518-4574-00 | REMEDYREPACK | 10 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 70771-1702-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71205-0276-06 | Proficient | 6 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71205-0535-06 | Proficient | 6 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71205-0663-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 71335-0370-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71335-0409-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Famotidine 20 mg 71335-1520-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71335-1950-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71335-2190-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71335-2805-00 | Bryant | 40 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71335-9748-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71610-0399-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71610-0470-53 | Aphena | 60 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 71821-0010-12 | VKT | 144230 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 72036-0026-14 | Harris | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 72189-0141-60 | direct | 60 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 72189-0543-20 | Direct_Rx | 20 tablets | — | AB | FDA listed | — |
| basic care heartburn prevention 20 mg 72288-0151-75 | Amazon.com | 90 tablets | — | — | FDA listed | — |
| basic care acid reducer 20 mg 72288-0194-00 | Amazon.com | 200 tablets | — | — | FDA listed | — |
| basic care acid reducer 20 mg 72288-0329-78 | Amazon.com | 100 tablets | — | — | FDA listed | — |
| Amazon Basic Care Acid Reducer 20 mg 72288-0363-14 | Amazon.com | 50 tablets | — | — | FDA listed | — |
| careone acid relief 20 mg 72476-0150-63 | Retail | 25 tablets | — | — | FDA listed | — |
| careone acid relief 20 mg 72476-0299-71 | Retail | 50 tablets | — | — | FDA listed | — |
| Curist Acid Relief 20 mg 72559-0032-23 | Little | 300 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 72657-0113-20 | GLENMARK | 200 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 72657-0132-01 | GLENMARK | 100 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 72789-0331-20 | PD-Rx | 20 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 72865-0214-01 | XLCare | 100 tablets | — | AB | FDA listed | — |
| Welmate Famotidine 20mg 20 mg 73581-0109-01 | YYBA | 100 tablets | — | — | FDA listed | — |
| topcare acid reducer 20 mg 76162-0300-71 | Topco | 50 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 76420-0712-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| equate famotidine 20 mg 79903-0115-99 | WALMART | 100 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 80425-0329-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 82804-0194-06 | Proficient | 6 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 82804-0980-00 | Proficient | 100 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 82868-0077-30 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 83008-0091-30 | Quality | 30 tablets | — | AB | FDA listed | — |
| Rolaids ACID DEFENSE 20 mg 84126-0367-25 | The | 25 tablets | — | — | FDA listed | — |
| Zantac 360 20 mg 85237-1926-01 | Select | 1 tablet | — | — | FDA listed | — |
| Acid Reducer Maximum Strength 20 mg 85828-0443-25 | Grocery | 25 tablets | — | — | FDA listed | — |
| Famotidine 20 mg 87441-0030-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 67296-2264-03 | Redpharm | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 85766-0221-01 | Sportpharm | 100 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 80425-0589-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Famotidine 20 mg 85534-0091-00 | HAWAII | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00172-5728-60 You're viewing this | 100 TABLET, FILM COATED in 1 BOTTLE (0172-5728-60) | $0.0286 / ea | $2.86 | 2001-04-16 | Active |
| 00172-5728-70 | 500 TABLET, FILM COATED in 1 BOTTLE (0172-5728-70) | $0.0286 / ea | $14.31 | 2001-04-16 | Active |
| 00172-5728-80 | 1000 TABLET, FILM COATED in 1 BOTTLE (0172-5728-80) | $0.0286 / ea | $28.62 | 2001-04-16 | Active |
You're viewing the smallest of 3 pack sizes for this product.
This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0286 NADAC).
This pack accounts for about 35% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 00172-5728-60?
What is the difference between NDC 00172-5728-60 and NDC 00172-5728-70?
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📄 Full prescribing information FDA SPL
🎯 Indications and 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 and 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 Reocurrence 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 ) A d m inistration ( 2.3 ): Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.
2.1Recommended 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 than 40 kg.
Table 1: Recommended Dosage and Duration of Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Normal Renal Function Indication Recommended Dosage Rec ommended Duration Active duodenal ulcer (DU) 40 mg once daily; or 20 mg twice daily a Up to 8 weeks b,c Active gastric ulcer 40 mg once daily Up to 8 weeks c Symptomatic nonerosive GERD 20 mg twice daily Up to 6 weeks c Erosive esophagitis diagnosed by endoscopy 20 mg twice daily; or 40 mg twice daily a Up to 12 weeks Pathological hypersecretory conditions d Starting dosage: 20 mg every 6 hours; adjust dosage to individual patient needs Maximum dosage 160 mg every 6 hours As clinically indicated Reduction of the risk of DU recurrence d 20 mg once daily 1 year c or as clinically indicated a Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies ( 14 )] . b In clinical trials, the majority of patients healed within 4 weeks.
For patients who do not heal after 4 weeks, consider an additional 2 to 4 weeks of treatment [see Clinical Studies ( 14.1 )]. c Longer treatment durations have not been studied in clinical trials [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . d In pediatric patients, the safety and effectiveness of famotidine tablets have not been established for the reduction of the risk of duodenal ulcer recurrence or for treatment of pathological hypersecretory conditions [see Use in Specific Populations ( 8.4 )] .
2.2Dosage in Renal Impairment Dosage adjustments of famotidine tablets are recommended for patients with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) [see Use in Specific Populations ( 8.6 )] . Table 2 shows the recommended maximum dosage of famotidine 20 mg or 40 mg tablets for patients with renal impairment, by indication. Use the lowest effective dose.
Some dosage adjustments may require switching to other formulations of famotidine (e.g., oral suspension, lower dose tablet). Table 2: Recommended Maximum Dosage of Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Moderate and Severe Renal Impairment Indication Rec o m mended Maximum Dosages Creatinine clearance 30 to 60 mL/minute Creatinine clearance less than 30 mL/minute Active duodenal ulcer (DU) 20 mg once daily; or 40 mg every other day 20 mg every other day a Active gastric ulcer 20 mg once daily; or 40 mg every other day 20 mg every other day a Symptomatic nonerosive GERD 20 mg once daily 20 mg every other day a Erosive esophagitis diagnosed by endoscopy b 20 mg once daily; or 40 mg every other day b 20 mg every other day a,b 40 mg once daily b 20 mg once daily b Pathological hypersecretory conditions c Avoid use d Reduction of the risk of DU recurrence c 20 mg every other day a (see footnote) e a An alternat…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 20 mg tablets: beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side. 40 mg tablets: tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side. Tablets: 20 mg, 40 mg ( 3 )
⛔ 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Central Nervous System (CNS) Adverse Reactions: Elderly patients and patients with renal impairment at increased risk; reduce the dosage. ( 2.2 , 5.1 , 8.5, 8.6 ) GI Malignancy : Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. ( 5.2 )
5.1Central Nervous System Adverse Reactions Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine tablets. Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )].
5.2Concurrent Gastric Malignancy In adults, symptomatic response to therapy with famotidine tablets does not preclude the presence of gastric malignancy. Consider evaluation for gastric malignancy in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with famotidine tablets.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 tablets 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 tablets, 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 17-91 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 tablets-treated patients: headache, dizziness and constipation. The following other adverse reactions were reported in less than 1% of patients in clinical trials: Body as a Whole: fever, asthenia, fatigue Cardiovascular: palpitations Gastrointestinal: elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic: thrombocytopenia Hypersensitivity: orbital edema, rash, conjunctival injection, bronchospasm Musculoskeletal: musculoskeletal pain, arthralgia Nervous System/Psychiatric: seizure, hallucinations, depression, anxiety, decreased libido, insomnia, somnolence Skin: pruritus, dry skin, flushing Special Senses: tinnitus, taste disorder Other: impotence
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, AV block, prolonged QT interval Gastrointestinal: cholestatic jaundice, hepatitis Hematologic: agranulocytosis, pancytopenia, leukopenia Hypersensitivity: anaphylaxis, angioedema, facial edema, urticaria Musculoskeletal: rhabdomyolysis, muscle cramps Nervous System/Psychiatric: confusion, agitation, paresthesia Respiratory: interstitial pneumonia Skin: toxic epidermal necrolysis/Stevens-Johnson syndrome
🔄 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 ) T izanidine (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 )
7.1Drugs 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 tablets 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.
7.2Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentrations of tizanidine, a CYP1A2 substrate. Avoid concomitant use with famotidine tablets. If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness. Refer to the full prescribing information for tizanidine.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Geriatric Use: Use the lowest effective dose for an elderly patient and monitor renal function. ( 2.2 , 5.1 , 8.5 ) Renal Impairment: Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage. ( 2.2 , 8.6 ) See 17 for Patient Counseling Information
8.1Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (se e Data) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine tablets.
While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
8.2Lactation Risk Summary There are limited data available on the presence of famotidine in human breast milk. There were no effects on the breastfed infant. There are no data on famotidine effects on milk production.
Famotidine is present in the milk of lactating rats (see Data) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for famotidine and any potential adverse effects on the breastfed child from famotidine tablets or from the underlying maternal condition. Data Animal Data Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of famotidine at least 600 times the usual human dose.
8.4Pediatric Use The safety and effectiveness of famotidine tablets have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and GERD (i.e., symptomatic nonerosive GERD, erosive esophagitis as diagnosed by endoscopy). The use of famotidine tablets and the recommended dosage of famotidine tablets in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine tablets in adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [s ee Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.2 , 12.3 )] .
In pediatric patients, the safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established. Famotidine 20 and 40 mg tablets are not recommended for use in pediatric patients weighing less than 40 kg because these tablet strengths exceed the recommended dose for these patients [ see Dosage and Administration ( 2.1 )] . For pediatric patients weighing less than 40 kg, consider another famotidine formulation (e.g., oral suspension, lower dose tablet).
8.5 Geriatri…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (se e Data) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine tablets.
While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of famotidine tablets have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and GERD (i.e., symptomatic nonerosive GERD, erosive esophagitis as diagnosed by endoscopy). The use of famotidine tablets and the recommended dosage of famotidine tablets in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine tablets in adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [s ee Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.2 , 12.3 )] .
In pediatric patients, the safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established. Famotidine 20 and 40 mg tablets are not recommended for use in pediatric patients weighing less than 40 kg because these tablet strengths exceed the recommended dose for these patients [ see Dosage and Administration ( 2.1 )] . For pediatric patients weighing less than 40 kg, consider another famotidine formulation (e.g., oral suspension, lower dose tablet).
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1442 famotidine tablets-treated patients in clinical studies, approximately 10% were 65 and older. In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. In postmarketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine tablets [ see Warnings and Precautions ( 5.1 )] .
Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine tablets may be greater in elderly patients, particularly those with impaired renal function [ see Use in Specific Populations ( 8.6 )] . In general, use the lowest effective dose of famotidine tablets for an elderly patient and monitor renal function [see Dosage and Administration ( 2.2 )].
🆘 Overdosage ▾
10 OVERDOSAGE The types of adverse reactions in overdosage of famotidine tablets are similar to the adverse reactions encountered with use of recommended dosages [ see Adverse Reactions ( 6.1 )] . In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.
Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis. There is limited experience on the usefulness of hemodialysis as a treatment for famotidine tablets overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine-2 (H 2 ) receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.
12.2Pharmacodynamics Adults Famotidine inhibited both basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration of famotidine tablets, the onset of the antisecretory effect occurred within one hour; the maximum effect was dose-dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 mg and 40 mg was 10 to 12 hours.
Single evening oral doses of 20 mg and 40 mg inhibited basal and nocturnal acid secretion in all subjects; mean nocturnal gastric acid secretion was inhibited by 86% and 94%, respectively, for a period of at least 10 hours. The same doses given in the morning suppressed food-stimulated acid secretion in all subjects. The mean suppression was 76% and 84%, respectively, 3 to 5 hours after administration, and 25% and 30%, respectively, 8 to 10 hours after administration.
In some subjects who received the 20 mg dose, however, the antisecretory effect was dissipated within 6 to 8 hours. There was no cumulative effect with repeated doses. The nocturnal intragastric pH was raised by evening doses of 20 mg and 40 mg of famotidine tablets to mean values of 5.0 and 6.4, respectively.
When famotidine tablets was given after breakfast, the basal daytime interdigestive pH at 3 and 8 hours after 20 mg or 40 mg of famotidine was raised to about 5. Famotidine had little or no effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine tablets.
In clinical pharmacology studies, systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine systems were not noted. Also, no anti-androgenic effects were noted. Serum hormone levels, including prolactin, cortisol, thyroxine (T4), and testosterone, were not altered after treatment with famotidine.
Pediatric Patients Pharmacodynamics of famotidine, assessed by gastric pH, were evaluated in 5 pediatric patients 2 to 13 years of age using the sigmoid Emax model. These data suggest that the relationship between serum concentration of famotidine and gastric acid suppression is similar to that observed in adults (see Table 3). Table 3: Serum Concentrations of Famotidine Associated with Gastric Acid Reduction in Famotidine Tablets-Treated Pediatric and Adult Patients a EC 50 (ng/mL) a Pediatric Patients 26 ± 13 Adults Healthy adult subjects 26.5 ±
10.3Adult patients with upper GI bleeding 18.7 ± 10.8 a Using the Sigmoid Emax model, serum concentrations of famotidine associated with 50% maximum gastric acid reduction are presented as means ± SD. In a study examining the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients, four pediatric patients ages 11 to 15 years of age using the oral formulation at a dose of 0.5 mg/kg, maintained a gastric pH above 5 for 13.5 ± 1.8 hours.
12.3Pharmacokinetics Absorption Famotidine is incompletely absorbed. The bioavailability of oral doses is 40 to 45%. Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence.
Peak famotidine plasma levels occur in 1 to 3 hours. Plasma levels after multiple dosages are similar to those after single doses. Distribution Fifteen to 20% of famotidine in plasma is protein bound.
Elimination Metabolism Famotidine undergoes minimal first-pass metabolism. Twenty-five to 30% of an oral dose was recovered in the urine as unchanged compound. The only metabolite identified in humans is the S-oxide.
Excretion Famotidine has an eliminatio…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine-2 (H 2 ) receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets. Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.
Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid storage of famotidine tablets at temperatures above 40°C (104°F).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
📋 Description ▾
11 DESCRIPTION The active ingredient in Famotidine Tablets USP is a histamine-2 (H 2 ) receptor antagonist. Famotidine, USP is [1-Amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propylidene] sulfamide and has the following structural formula: C 8 H 15 N 7 O 2 S 3 M.W. 337.45 Each Famotidine Tablet USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and has the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide.
In addition the 20 mg contains lactose monohydrate, red iron oxide and triacetin and the 40 mg contains FD&C blue No. 2 aluminum lake and FD&C yellow No. 6 aluminum lake.
Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Central Nervous System (CNS) Adverse Reactions Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see Warnings and Precautions ( 5.1 )] . Report symptoms immediately to a healthcare provider. QT Prolongation Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [ see Use in Specific Populations ( 8.6 )] .
Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider. Administration Advise patients: Take famotidine tablets once daily before bedtime or twice daily in the morning and before bedtime, as recommended. Famotidine tablets may be taken with or without food.
Famotidine tablets may be given with antacids. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454 Rev. F 1/2019