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Famotidine 40 mg Tablet, 100-count — NDC 70756-0052-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Famotidine 40 mg Tablet, 100-count — NDC 70756-052-11 (Billing 70756-0052-11)

by Lifestar Pharma LLC · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Famotidine 40 mg Tablet from Lifestar Pharma LLC, marketed since Oct 2023 and currently FDA-listed; retail pharmacies pay about $0.0483 per tablet (NADAC).

NDC 70756-0052-11
🏷️ FDA NDC (as labeled) 70756-052-11 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0483 NADAC Per package$4.83 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1796/unit · Part D plans $0.0827/unit — full pricing hub ↓
Product page 70756-0052-12 Also comes in: 1000 tablets 70756-052-12
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0809-2026
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70756-052-11
Product NDC 70756-052
11-digit billing NDC 70756005211
NCPDP billing unit EA — each (per item)
RxCUI 284245, 310273
UNII 5QZO15J2Z8
UPC 0370756051114, 0370756052111
Application # ANDA075302
SPL Set ID 044a510f-33df-4484-8f07-d821f52b9376
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 2023-10-19
Route ORAL
Dosage form TABLET
Substance FAMOTIDINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 49200030000340
GCN Seq No 011678
GCN 46431
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 40 MG TABLET
FDB brand name Famotidine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 011678
  • GCN: 46431
  • GPI-14 (Medi-Span): 49200030000340
  • HICL (First Databank): 004521
  • AHFS class code: 04:92.00.00
  • RxCUI (RxNorm): 284245
Why two NDCs? The FDA registers this code as 70756-052-11 — a 5-3-2 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 product segment → 70756-0052-11. 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.

RxNorm drug class

This medicine belongs to the Histamine-2 Receptor Antagonist class.

Pharmacologic class Histamine-2 Receptor Antagonist
Drug family (ATC) H2-receptor antagonists
How it works Histamine H2 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name FAMOTIDINE 40 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
  • It reduces stomach acid. Over-the-counter versions relieve and prevent heartburn from acid indigestion and sour stomach. Prescription versions treat ulcers, GERD and erosive esopha...
  • With the over-the-counter tablets, swallow one with water and do not chew it. To prevent heartburn, take it shortly before a food or drink that triggers it. Do not take more than 2...
  • Headache, dizziness, constipation and diarrhea are the most common, and they are usually mild. Call your doctor if you have confusion, hallucinations, seizures, a rash with swellin...
  • Not always. Famotidine can lower absorption of some drugs that need stomach acid and can raise tizanidine levels. Tell me or your doctor everything you take before you start.
📖 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.

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 $0.048 $4.83 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1796 $17.96 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.0827 $8.27 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.052 $0.048
▼ Down 7% over the last 10 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
70756-0052-11 You're viewing this 100 TABLET in 1 BOTTLE $0.0483 / ea $4.83 2023-10-19 — Active
70756-0052-12 70756-052-12 Main listing 1000 TABLET in 1 BOTTLE $0.0483 / ea $48.34 2023-10-19 — Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0483 NADAC).

This pack accounts for about 3.8% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 70756-0052-12?
Both are Famotidine 40 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 70756-0052-12 is the 1000 tablets package.
What NDC number is used to bill for this package of Famotidine 40 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Famotidine 40 mg 00172-5729-60 Teva 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 31722-0018-01 Camber 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 50268-0304-15 AvPAK 50 tablets $0.048 AB Availability likely —
Famotidine 40 mg 61442-0122-01 Carlsbad 2400 tablets $0.048 AB Availability likely —
famotidine 40 mg 62135-0808-90 Chartwell 90 tablets $0.048 AB Availability likely —
Famotidine 40 mg 64980-0624-01 Rising 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 65862-0860-01 Aurobindo 100 tablets $0.048 — Availability likely —
Famotidine 40 mg 67877-0843-01 Ascend 100 tablets $0.048 AB Discontinued —
Famotidine 40 mg 67877-0889-01 Ascend 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 68001-0398-00 BluePoint 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 69367-0401-10 Westminster 1000 tablets $0.048 AB Availability likely —
Famotidine 40 mg 70710-1684-00 Zydus 1000 tablets $0.048 AB Availability likely —
Famotidine 40 mgthis 70756-0052-11 Lifestar 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 72205-0146-05 Novadoz 500 tablets $0.048 AB Availability likely —
Pepcid 40 mg 00187-4440-10 Bausch 100 tablets — AB FDA listed —
Famotidine 40 mg 00615-8559-05 NCS 15 tablets — AB FDA listed —
Famotidine 40 mg 10267-5690-01 Contract 100 tablets — AB FDA listed —
Famotidine 40 mg 43063-0533-30 PD-Rx 30 tablets — AB FDA listed —
Famotidine 40 mg 43063-0696-30 PD-Rx 30 tablets — AB FDA listed —
Famotidine 40 mg 46708-0294-10 Alembic 100 tablets — AB FDA listed —
Famotidine 40 mg 50090-1432-00 A-S 30 tablets — AB FDA listed —
Famotidine 40 mg 50090-6790-00 A-S 30 tablets — AB FDA listed —
Famotidine 40 mg 50090-6916-00 A-S 90 tablets — AB FDA listed —
Famotidine 40 mg 50090-7196-00 A-S 90 tablets — AB FDA listed —
Famotidine 40 mg 50090-7966-00 A-S 90 tablets — AB FDA listed —
Famotidine 40 mg 50090-7981-00 A-S 30 tablets — AB FDA listed —
Famotidine 40 mg 50090-7982-00 A-S 90 tablets — AB FDA listed —
Famotidine 40 mg 51407-0684-01 Golden 3600 tablets — AB FDA listed —
Famotidine 40 mg 51655-0102-26 Northwind 90 tablets — AB FDA listed —
Famotidine 40 mg 55111-0120-01 Dr.Reddy's 100 tablets — AB FDA listed —
Famotidine 40 mg 60760-0736-60 St. 60 tablets — AB FDA listed —
Famotidine 40 mg 60760-0843-07 ST. 7 tablets — AB FDA listed —
Famotidine 40 mg 60760-0937-07 ST. 7 tablets — AB FDA listed —
Famotidine 40 mg 62332-0002-10 Alembic 100 tablets — AB FDA listed —
Famotidine 40 mg 63187-0908-30 Proficient 30 tablets — AB FDA listed —
Famotidine 40 mg 63629-2014-01 Bryant 1000 tablets — AB FDA listed —
Famotidine 40 mg 63629-2015-01 Bryant 100 tablets — AB FDA listed —
Famotidine 40 mg 63629-2782-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 68071-3413-03 NuCare 30 tablets — AB FDA listed —
Famotidine 40 mg 68071-3521-03 NuCare 30 tablets — AB FDA listed —
Famotidine 40 mg 68071-3584-03 NuCare 30 tablets — AB FDA listed —
Famotidine 40 mg 68071-4197-03 NuCare 30 tablets — AB FDA listed —
Famotidine 40 mg 68788-8518-03 Preferred 30 tablets — AB FDA listed —
Famotidine 40 mg 68788-8733-03 Preferred 30 tablets — AB FDA listed —
Famotidine 40 mg 70518-4084-01 REMEDYREPACK 90 tablets — AB FDA listed —
Famotidine 40 mg 70518-4394-00 REMEDYREPACK 90 tablets — AB FDA listed —
Famotidine 40 mg 70771-1703-00 Zydus 1000 tablets — AB FDA listed —
Famotidine 40 mg 71205-0257-30 Proficient 30 tablets — AB FDA listed —
Famotidine 40 mg 71205-0634-30 Proficient 30 tablets — AB FDA listed —
Famotidine 40 mg 71205-0781-30 Proficient 30 tablets — AB FDA listed —
Famotidine 40 mg 71335-0231-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 71335-2442-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 71335-2527-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 71335-9615-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 71335-9724-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 72162-1737-00 Bryant 1000 tablets — AB FDA listed —
Famotidine 40 mg 72189-0207-30 direct 30 tablets — AB FDA listed —
Famotidine 40 mg 72789-0345-30 PD-Rx 30 tablets — AB FDA listed —
Famotidine 40 mg 72789-0427-90 PD-Rx 90 tablets — AB FDA listed —
Famotidine 40 mg 72789-0453-30 PD-Rx 30 tablets — AB FDA listed —
Famotidine 40 mg 72865-0215-01 XLCare 100 tablets — AB FDA listed —
Famotidine 40 mg 76420-0713-01 Asclemed 100 tablets — AB FDA listed —
Famotidine 40 mg 82804-0228-30 Proficient 30 tablets — AB FDA listed —
Famotidine 40 mg 82804-0981-00 Proficient 100 tablets — AB FDA listed —
Famotidine 40 mg 85766-0222-01 Sportpharm 100 tablets — AB FDA listed —
Famotidine 40 mg 85534-0092-00 HAWAII 30 tablets — AB FDA listed —
Famotidine 40 mg 68788-4144-03 Preferred 30 tablets — AB FDA listed —
Famotidine 40 mg 72789-0589-30 PD-Rx 30 tablets — AB FDA listed —
Famotidine 40 mg 67296-2330-02 Redpharm 20 tablets — AB FDA listed —
Famotidine 40 mg 53401-0036-53 Aphena 60 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color Brown
ShapeRound
ImprintL;52
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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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.
  • 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 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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.
  • 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 Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • 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 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.
  • 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?
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.

Manufacturer & labeler

LabelerLifestar Pharma LLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA075302 (ANDA)
Labeler code70756
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio155 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 135 words ▾

1 INDICATIONS AND USAGE Famotidinetablets 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. Famotidinetablets 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 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 Gastric Ulcer 40 mg once daily GERD 20 mg twice daily Erosive Esophagitis 20 mg twice daily; or 40 mg twice daily Adults Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Recurrence 20 mg once daily See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration.

( 2.1 , 2.2 ) Administration ( 2.3 ): Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.

2.1Recommended Dosage Table 1 shows the recommended dosage of famotidine tablets 20 mg and 40 mg tablets in adult and pediatric patients weighing 40 kg and greater with normal renal function. The use of famotidine tablets 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 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 tablets 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; 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 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 DU recurrence c 20 mg every other day a (see footnote) e a An… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 59 words ▾

3 DOSAGE FORMS AND STRENGTHS Famotidine tablets, USP 20 mg: Beige colored, round shaped, film-coated, biconvex tablets, debossed with "L" on one side and "51" on other side. Famotidine tablets, USP 40 mg: Tan colored, round shaped, film-coated, biconvex tablets, debossed with "L" on one side and "52" 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 179 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 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 ~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 Lifestar Pharma LLC at 1-888-995-4337 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 were 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 193 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 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 ~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 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 [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 tablets 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 1442 famotidine tablets-t… [Excerpted — this section continues on DailyMed.]

🆘 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 tablets 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 tablets 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 were given after breakfast, the basal daytime interdigestive pH at 3 and 8 hours after 20 mg or 40 mg of famotidine tablets were raised to about 5. Famotidine tablets 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 tablets 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 tablets.

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 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 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-o… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 101 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Famotidine tablets, USP are supplied as follows: 20 mg tablets: Beige colored, round shaped, film-coated, biconvex tablets, debossed with "L" on one side and "51" on other side. NDC 70756-051-11 bottles of 100 with child-resistant closure NDC 70756-051-12 bottles of 1000 40 mg tablets: Tan colored, round shaped, film-coated, biconvex tablets, debossed with "L" on one side and "52" on other side. NDC 70756-052-11 bottles of 100 with child-resistant closure NDC 70756-052-12 bottles of 1000 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, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate. structure

💬 Information for Patients 151 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. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd.

Mahwah, NJ 07430 USA Made in India Revised: January 2023, V-02

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Active Duodenal Ulcer In a U.S. multicenter, double-blind trial in adult outpatients with endoscopically confirmed duodenal ulcer (DU), orally administered famotidine tablets were compared to placebo. As shown in Table 4, 70% of patients treated with famotidine tablets 40 mg at bedtime were healed by Week 4. Most patients' DU healed within 4 weeks.

Patients not healed by Week 4 were continued in the trial. By Week 8, 83% of patients treated with famotidine tablets had healed DU, compared to 45% of patients treated with placebo. The incidence of DU healing with famotidine tablets were greater than with placebo at each time point based on proportion of endoscopically confirmed healed DUs.

Trials have not assessed the safety of famotidine tablets in uncomplicated active DU for periods of more than 8 weeks. Table 4: Patients with Endoscopically Confirmed Healed Duodenal Ulcers Famotidine Tablets 40 mg at bedtime (N=89) Famotidine Tablets 20 mg twice daily (N=84) Placebo at bedtime (N=97) Week 2 32% a 38% a 17% Week 4 70% a 67% a 31% a p<0.001 vs. placebo In this study, time to relief of daytime and nocturnal pain was shorter for patients receiving famotidine tablets than for patients receiving placebo; patients receiving famotidine tablets also took less antacid than patients receiving placebo.

14.2Active Gastric Ulcer In both a U.S. and an international multicenter, double-blind trials in patients with endoscopically confirmed active gastric ulcer (GU), orally administered famotidine tablets 40 mg at bedtime was compared to placebo. Antacids were permitted during the trials, but consumption was not significantly different between the famotidine tablets and placebo groups. As shown in Table 5, the incidence of GU healing confirmed by endoscopy (dropouts counted as unhealed) with famotidine tablets were greater than placebo at Weeks 6 and 8 in the U.S. trial, and at Weeks 4, 6 and 8 in the international trial.

In these trials, most famotidine tablets-treated patients healed within 6 weeks. Trials have not assessed the safety of famotidine tablets in uncomplicated active GU for periods of more than 8 weeks. Table 5: Patients with Endoscopically Confirmed Healed Gastric Ulcers U.S.

Study (N=149) International Study (N=294) Famotidine Tablets 40 mg at bedtime (N=74) Placebo at bedtime (N=75) Famotidine Tablets 40 mg at bedtime (N=149) Placebo at bedtime (N=145) Week 4 45% 39% 47% a 31% Week 6 66% a 44% 65% a 46% Week 8 78% b 64% 80% a 54% a p≤0.01 vs. placebo b p≤0.05 vs. placebo Time to complete relief of daytime and nighttime pain was statistically significantly shorter for patients receiving famotidine tablets than for patients receiving placebo; however, neither trial demonstrated a statistically significant difference in the proportion of patients whose pain was relieved by the end of the trial (Week 8).

14.3Symptomatic Gastroesophageal Reflux Disease (GERD) Orally administered famotidine tablets were compared to placebo in a U.S. trial that enrolled patients with symptoms of GERD and without endoscopic evidence of esophageal erosion or ulceration. As shown in Table 6, patients treated with famotidine tablets 20 mg twice daily had greater improvement in symptomatic GERD than patients treated with 40 mg at bedtime or placebo. Table 6: Patients with Improvement of Symptomatic GERD (N=376) Famotidine Tablets 20 mg twice daily (N=154) Famotidine Tablets 40 mg at bedtime (N=149) Placebo at bedtime (N=73) Week 6 82% a 69% 62% a p≤0.01 vs. placebo

14.4Erosive Esophagitis due to GERD Healing of endoscopically verified erosion and symptomatic improvement were studied in a U.S. and an international double-blind trials. Healing was defined as complete resolution of all erosions visible with endoscopy. The U.S. trial comparing orally administered famotidine tablets 40 mg twice daily to placebo and orally administered famotidine tablets 20 mg twice daily showed a significantly greater percentage of healing of erosi… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 174 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenic potential of famotidine was assessed in a 106-week oral carcinogenicity study in rats and a 92-week oral carcinogenicity study in mice. In the 106-week study in rats and the 92-week study in mice at oral doses of up to 2000 mg/kg/day (approximately 243 and 122 times, respectively, based on body surface area, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis), there was no evidence of carcinogenic potential for famotidine.

Famotidine was negative in the microbial mutagen test (Ames test) using Salmonella typhimurium and Escherichia coli with or without rat liver enzyme activation at concentrations up to 10,000 mcg/plate. In in vivo studies in mice, with a micronucleus test and a chromosomal aberration test, no evidence of a mutagenic effect was observed. In studies with rats given oral doses of up to 2000 mg/kg/day (approximately 243 times, based on body surface area, the recommended human dose of 80 mg per day) fertility and reproductive performance were not affected.

📄 Package Label / Principal Display Panel 52 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-051-11 Famotidine Tablets, USP 20 mg Rx only 100 Tablets NDC 70756-051-12 Famotidine Tablets, USP 20 mg Rx only 1000 Tablets NDC 70756-052-11 Famotidine Tablets, USP 40 mg Rx only 100 Tablets NDC 70756-052-12 Famotidine Tablets, USP 40 mg Rx only 1000 Tablets 20mg100label 20mg1000label 40mg100label 40mg1000label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
3.6K
Units reimbursed last 4 qtrs
141.9K
Gross reimbursed last 4 qtrs
$25.5K
Avg / prescription
$7.09
Avg / unit
$0.1796
Latest quarter Q1 2026
710Rx
Medicaid pays / ea
$0.1796
gross reimbursed
vs
NADAC / ea
$0.0483
acquisition cost
=
Spread
+$0.1313
+272% 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 ⓘ
33% FFS 67% MCO
Fee-for-service · 1,195 Rx Managed care · 2,396 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: 4,894 units · 82.8 per 100k residents WI Michigan: 21,653 units · 216 per 100k residents MI New York: 29,524 units · 151 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,715 units · 53.5 per 100k residents IA Illinois: 1,594 units · 12.7 per 100k residents IL Indiana: 5,491 units · 80.0 per 100k residents IN Ohio: 2,384 units · 20.2 per 100k residents OH Pennsylvania: 11,250 units · 86.8 per 100k residents PA New Jersey: 9,433 units · 102 per 100k residents NJ Massachusetts: no data reported MA California: 8,392 units · 21.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 4,219 units · 68.1 per 100k residents MO Kentucky: 1,560 units · 34.5 per 100k residents KY West Virginia: 2,570 units · 145 per 100k residents WV Virginia: no data reported VA Maryland: 22,894 units · 370 per 100k residents MD Connecticut: 1,634 units · 45.2 per 100k residents 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: 540 units · 7.6 per 100k residents TN North Carolina: 2,116 units · 19.5 per 100k residents NC South Carolina: no data reported SC Delaware: 349 units · 33.9 per 100k residents DE Oklahoma: no data reported OK Louisiana: 1,534 units · 33.5 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 990 units · 9.0 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,557 units · 8.4 per 100k residents TX Florida: 4,597 units · 20.3 per 100k residents FL
Units reimbursed · per 100k residents
7.6370
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 Maryland 370 /100k
2 Michigan 216 /100k
3 New York 151 /100k
4 West Virginia 145 /100k
5 New Jersey 102 /100k
6 Pennsylvania 86.8 /100k
7 Wisconsin 82.8 /100k
8 Indiana 80.0 /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.
1000 tablets70756-0052-12 90,351 Rx · $837,322
100 tablets this page70756-0052-11 3,591 Rx · $25,477
Drug total (last 4 qtrs): 93,942 Rx · 3,654,850 units · $862,799 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.
← 70756-0051-11 · Lifestar 70756-0053-12 · Lifestar →
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.