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Famotidine 20 mg Tablet, Film Coated — NDC 00904-7193-06 package photo

Famotidine 20 mg Tablet, Film Coated

by Major Pharmaceuticals · 50 BLISTER PACK in 1 CARTON (0904-7193-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
NDC 00904-7193-06
🏷️ FDA NDC (as labeled) 0904-7193-06 billing pads the labeler segment with a zero
This package
Contains1 tablet, film coated in 1 blister pack Cost per ea$0.0286 NADAC Per package$1.43 / 50 tablet Pack sizes2 compare ↓
Also priced by: Medicaid pays $26.91/unit · Part D plans $0.0827/unit — full pricing hub ↓
Also comes in: 1 tablet 00904-7193-61
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Famotidine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Nov 6, 2025 — Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. (Fresenius Kabi USA, LLC) · FDA recall D-0182-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0904-7193-06
Product NDC 0904-7193
11-digit billing NDC 00904719306
NCPDP billing unit EA — each (per item)
UNII 5QZO15J2Z8
Application # ANDA075718
SPL Set ID 3e6d167f-91e4-4122-911d-d3da66386f44
Established class (EPC) Histamine-2 Receptor Antagonist
Mechanism of action Histamine H2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-04-16
Route ORAL
Dosage form TABLET, FILM COATED
Substance FAMOTIDINE
GCN Seq No 011677
GCN 46430
HICL code 004521
Ingredient (HICL) Famotidine
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2D
Therapeutic class — specific (HIC3) Histamine H2-Receptor Inhibitors
AHFS code 04:92.00.00
AHFS class Other Antihistamines
FDB label name FAMOTIDINE 20 MG TABLET
FDB brand name Famotidine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0904-7193-06 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00904-7193-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA075718 (ANDA)
Labeler code00904
First marketedApr 2001
Product typeHuman Prescription Drug
Portfolio629 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name FAMOTIDINE 20 MG TABLET Ingredient Famotidine
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • Famotidine is an acid reducer. Over-the-counter products like Acid Reducer or Calmicid AC are mainly for relieving or preventing heartburn and indigestion. Prescription famotidine...
  • Swallow the tablet whole with a full glass of water — don't chew it. For heartburn relief, you can take it when symptoms start. To prevent heartburn before a meal, take it 10 to 60...
  • Most people do just fine with famotidine. The most common things that come up are headache, dizziness, and constipation. Some people notice nausea or stomach discomfort too. These...
  • What side effects should I actually expect?
📖 Read our full Famotidine guide →
6
Nutrient depletion considerations

Famotidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Famotidine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow
ShapeRound
ImprintC;119
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

  • 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.
  • 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.
  • 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.
  • 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.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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.
  • 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.
  • 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.
  • 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.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.029 $1.43 / 50 tablet
Medicaid paysCMS SDUD · 12 mo $26.91 $1,345.62 / 50 tablet
Medicare drug plans payPart D · Q2 2026 $0.0827 $4.14 / 50 tablet
NADAC price history (per ea) — tap or hover for the price & month
Nov 2022 Dec 2025 Apr 2026 Aug 2026 $0.035 $0.029
▼ Down 5% over the last 13 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Famotidine 20 mg 00172-5728-60 Teva 100 tablets $0.029 AB Availability likely —
Famotidine 20 mgthis 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2001
On the market since
Apr 2001
📍
2026
Currently FDA-listed
25 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00904-7193-06, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.1K
Units reimbursed last 4 qtrs
2.1K
Gross reimbursed last 4 qtrs
$57.7K
Avg / prescription
$54.05
Avg / unit
$26.9123
Latest quarter Q4 2025
158Rx
Medicaid pays / ea
$26.9123
gross reimbursed
vs
NADAC / ea
$0.0286
acquisition cost
=
Spread
+$26.8837
+93999% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
28% FFS 72% MCO
Fee-for-service · 300 Rx Managed care · 767 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: 211 units · 15.0 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 51 units · 5.5 per 100k residents SD Iowa: 55 units · 1.7 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 448 units · 3.8 per 100k residents OH Pennsylvania: 39 units · 0.3 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 668 units · 1.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 148 units · 2.4 per 100k residents MO Kentucky: 381 units · 8.4 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 142 units · 2.0 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.315.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Hampshire 15.0 /100k
2 Kentucky 8.4 /100k
3 South Dakota 5.5 /100k
4 Ohio 3.8 /100k
5 Missouri 2.4 /100k
6 Tennessee 2.0 /100k
7 Iowa 1.7 /100k
8 California 1.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tablet00904-7193-61 12,276 Rx · $91,271
1 tablet this page00904-7193-06 1,067 Rx · $57,673
Drug total (last 4 qtrs): 13,343 Rx · 34,593 units · $148,944 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Famotidine — the program that covers self-administered drugs. 29 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Famotidine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$40.22M
Claims incl. refills
3.8M
Beneficiaries
2.6M
Spend / beneficiary
$15.35
Spend / claim
$10.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00904-7193-06 You're viewing this 50 BLISTER PACK in 1 CARTON (0904-7193-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK $0.0286 / ea $1.43 2022-08-10 Active
00904-7193-61 100 BLISTER PACK in 1 CARTON (0904-7193-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK $0.0286 / ea $2.86 2001-04-16 Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0286 NADAC).

This pack accounts for about 8.0% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00904-7193-06?
NDC 00904-7193-06 is listed by the FDA — 50 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Famotidine 20 mg Tablet, Film Coated?
Bill NDC 00904-7193-06 — the 11-digit billing format is 00904719306. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 151 words ▾

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 is 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 ~3 min read ▾

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 GastricUlcer 40 mg once daily GERD 20 mg twice daily Erosive Esophagitis 20 mg twice daily; or40 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.

2.1Recommended 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 Recommended 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 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 Recommended Maximum Dosages Creatinine clearance 30 to 60 mL/minute Creatinine clearance less than 30 mL/minute Active duodenal ulcer (DU) 20 mg once daily; or40 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 40 mg once daily b 20 mg every other day a,b 20 mg once daily b Pathological hypersecretory conditions c Avoid use d Reduction of the risk of DUrecurrence c 20 mg every other day a (see footnote) e a An alternate dosage regimen is…

💊 Dosage Forms and Strengths 59 words ▾

3 DOSAGE FORMS AND STRENGTHS • Famotidine tablets USP, 20 mg are yellow, film-coated, round shaped tablets with ‘C’ 119 on one side and plain on other side. • Famotidine tablets USP, 40 mg are yellow, film-coated, round shaped tablets with ‘C’ 120 on one side and plain on other side. Tablets: 20 mg, 40 mg ( 3 )

⛔ Contraindications 45 words ▾

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 178 words ▾

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 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 ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 orwww.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 was studied in 7 U.S. and international placebo- and active-controlled trials in approximately 2,500 patients [see Clinical Studies (14)]. A total of 1,442 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. 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 syndro

🔄 Drug Interactions 191 words ▾

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 orexcessive 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 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. If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness. Refer to the full prescribing information for tizanidine

👥 Use in Specific Populations ~3 min read ▾

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 )

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 (see 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 2,000 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.

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 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 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 and the recommended dosage of famotidine in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine in adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [see 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).

8.5Geriatric Use Of the 1,442 famotidine-treated patients in clinical studies, approximately 10% were…

🤰 Pregnancy ~1 min read ▾

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 (see 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 2,000 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.

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 172 words ▾

8.4Pediatric Use The safety and effectiveness of famotidine 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 and the recommended dosage of famotidine in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine in adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [see 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 122 words ▾

8.5Geriatric Use Of the 1,442 famotidine-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 [see Warnings and Precautions ( 5.1 )].

Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine 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 for an elderly patient and monitor renal function [see Dosage and Administration ( 2.2 )].

🆘 Overdosage 89 words ▾

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 overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

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, 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 to mean values of 5 and 6.4, respectively.

When famotidine tablets were 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.

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 (T 4 ), 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 E max 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-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 E max 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 elimination half-life of 2.5 to 3.5 hou…

🧬 Mechanism of Action 51 words ▾

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 108 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Famotidine tablets USP, 20 mg are yellow, film-coated, round shaped tablets with ‘C’ 119 on one side and plain on other side and are supplied Cartons of 50 film-coated tablets (10 film-coated tablets each blister pack x 5), NDC 0904-7193-06 Cartons of 100 film-coated tablets (10 film-coated tablets each blister pack x 10), NDC 0904-7193-61 WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container.

📋 Description 139 words ▾

11 DESCRIPTION The active ingredient in famotidine tablets, USP is a histamine-2 (H 2 ) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propanimidamide. The molecular formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45.

Its structural formula is: Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The film coating consists hydroxypropyl methylcellulose, polyethylene glycol, synthetic yellow iron oxide and titanium dioxide. Famotidine, USP is a white to pale yellowish-white, crystalline powder that is freely soluble in dimethylformamide, glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate. structure

💬 Information for Patients 167 words ▾

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. Rx only Distributor: Dr.

Reddy’s Laboratories Inc., Princeton, NJ 08540 Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Made in India Revised: 1120

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00904-7192-40 · Major 00904-7194-61 · Major →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.