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Famotidine 40 mg Tablet, 60-count — NDC 53401-0036-53 package photo

Famotidine 40 mg Tablet, 60-count

by Aphena Pharma Solutions - Tennessee, LLC · 60 TABLET in 1 BOTTLE (53401-036-53)
NDC 53401-0036-53
🏷️ FDA NDC (as labeled) 53401-036-53 billing pads the product segment with a zero
This package
Contains60-count Pack sizes2 compare ↓
Also comes in: 90 tablets 53401-0036-60
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 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

FDA NDC (as labeled) 53401-036-53
Product NDC 53401-036
11-digit billing NDC 53401003653
Application # ANDA075805
SPL Set ID 5b9c6f47-3071-4bbd-e063-6294a90aaec5
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
Substance FAMOTIDINE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 53401-036-53 — 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 → 53401-0036-53. 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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderCARLSBAD TECHNOLOGY INC
FDA applicationANDA075805 (ANDA)
Labeler code53401
First marketedApr 2001
Product typeHuman Prescription Drug
Portfolio800 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

📗 Our plain-language guide HelloPharmacist
  • Great question. Antacids (like Tums) neutralize acid that's already in your stomach — they work fast but don't last long. Famotidine is different: it actually blocks a signal in yo...
  • What exactly does famotidine do — and how is it different from antacids?
  • The over-the-counter tablets are meant to relieve heartburn when it happens, or to prevent it if you take them 10 to 60 minutes before a meal that usually causes trouble. You shoul...
  • Can I take the OTC version whenever I have heartburn, or is there a limit?
📖 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 white
ShapeRound
ImprintCTI;122
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 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 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 VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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.
  • 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.

8 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 90 tablets
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 40 mg 31722-0018-01 Camber 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 68001-0398-00 BluePoint 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 67877-0843-01 Ascend 100 tablets $0.048 AB Discontinued —
Famotidine 40 mg 70710-1684-00 Zydus 1000 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 65862-0860-01 Aurobindo 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 69367-0401-10 Westminster 1000 tablets $0.048 AB Availability likely —
Famotidine 40 mg 50268-0304-15 AvPAK 50 tablets $0.048 AB Availability likely —
Famotidine 40 mg 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 —
Famotidine 40 mg 00172-5729-60 Teva 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 64980-0624-01 Rising 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 67877-0889-01 Ascend 100 tablets $0.048 AB Availability likely —
Famotidine 40 mg 55111-0120-01 Dr.Reddy's 100 tablets — AB FDA listed —
Famotidine 40 mg 63187-0908-30 Proficient 30 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 72865-0215-01 XLCare 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 60760-0736-60 St. 60 tablets — AB FDA listed —
Famotidine 40 mg 71205-0781-30 Proficient 30 tablets — AB FDA listed —
Famotidine 40 mg 50090-7981-00 A-S 30 tablets — AB FDA listed —
Famotidine 40 mg 68788-8518-03 Preferred 30 tablets — AB FDA listed —
Famotidine 40 mg 71335-2527-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 43063-0533-30 PD-Rx 30 tablets — AB FDA listed —
Famotidine 40 mg 60760-0843-07 ST. 7 tablets — AB FDA listed —
Famotidine 40 mg 72789-0453-30 PD-Rx 30 tablets — AB FDA listed —
Famotidine 40 mg 10267-5690-01 Contract 100 tablets — AB FDA listed —
Famotidine 40 mg 63629-2782-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 68071-3584-03 NuCare 30 tablets — AB FDA listed —
Famotidine 40 mg 72789-0345-30 PD-Rx 30 tablets — AB FDA listed —
Famotidine 40 mg 76420-0713-01 Asclemed 100 tablets — AB FDA listed —
Pepcid 40 mg 00187-4440-10 Bausch 100 tablets — AB FDA listed —
Famotidine 40 mg 46708-0294-10 Alembic 100 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 82804-0228-30 Proficient 30 tablets — AB FDA listed —
Famotidine 40 mg 50090-7966-00 A-S 90 tablets — AB FDA listed —
Famotidine 40 mg 51407-0684-01 Golden 3600 tablets — AB FDA listed —
Famotidine 40 mg 72189-0207-30 direct 30 tablets — AB FDA listed —
Famotidine 40 mg 43063-0696-30 PD-Rx 30 tablets — AB FDA listed —
Famotidine 40 mg 51655-0102-26 Northwind 90 tablets — AB FDA listed —
Famotidine 40 mg 63629-2014-01 Bryant 1000 tablets — AB FDA listed —
Famotidine 40 mg 70771-1703-00 Zydus 1000 tablets — AB FDA listed —
Famotidine 40 mg 71335-0231-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 71335-9615-01 Bryant 30 tablets — AB FDA listed —
Famotidine 40 mg 82804-0981-00 Proficient 100 tablets — AB FDA listed —
Famotidine 40 mg 00615-8559-05 NCS 15 tablets — AB FDA listed —
Famotidine 40 mg 50090-7982-00 A-S 90 tablets — AB FDA listed —
Famotidine 40 mg 62332-0002-10 Alembic 100 tablets — AB FDA listed —
Famotidine 40 mg 63629-2015-01 Bryant 100 tablets — AB FDA listed —
Famotidine 40 mg 68071-3521-03 NuCare 30 tablets — AB FDA listed —
Famotidine 40 mg 68071-4197-03 NuCare 30 tablets — AB FDA listed —
Famotidine 40 mg 70518-4084-01 REMEDYREPACK 90 tablets — AB FDA listed —
Famotidine 40 mg 60760-0937-07 ST. 7 tablets — AB FDA listed —
Famotidine 40 mg 68788-8733-03 Preferred 30 tablets — AB FDA listed —
Famotidine 40 mg 70518-4394-00 REMEDYREPACK 90 tablets — AB FDA listed —
Famotidine 40 mg 72789-0427-90 PD-Rx 90 tablets — AB FDA listed —
Famotidine 40 mg 50090-7196-00 A-S 90 tablets — AB FDA listed —
Famotidine 40 mg 68071-3413-03 NuCare 30 tablets — AB FDA listed —
Famotidine 40 mg 71335-2442-01 Bryant 30 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 mgthis 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

🏛️
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.

📊 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 Marketing startStatus
53401-0036-53 You're viewing this 60 TABLET in 1 BOTTLE (53401-036-53) 2026-09-14 Active
53401-0036-60 90 TABLET in 1 BOTTLE (53401-036-60) 2026-09-14 Active

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

Pack size FAQ

What quantity is in NDC 53401-0036-53?
NDC 53401-0036-53 is a 60-count package — 60 tablet in 1 bottle.
What is the difference between NDC 53401-0036-53 and NDC 53401-0036-60?
Both are Famotidine 40 mg Tablet — the drug itself is identical. NDC 53401-0036-53 is the 60-count package, while NDC 53401-0036-60 is the 90 tablets package.
What NDC number is used to bill for this package of Famotidine 40 mg Tablet?
Bill NDC 53401-0036-53 — the 11-digit billing format is 53401003653. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 53401-036-53, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 53401-0036-53, written without dashes as 53401003653. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 53401-0036-53, the first segment (53401) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0036) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (53) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 90 tablets (53401-0036-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53401-0035-53 · Aphena 53401-0037-53 · Aphena →
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.