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Famotidine 20 mg Tablet, 30-count — NDC 63187-0723-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Famotidine 20 mg Tablet, 30-count — NDC 63187-723-30 (Billing 63187-0723-30)

by Proficient Rx LP · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Famotidine 20 mg Tablet from Proficient Rx LP, marketed since Jan 2016 and currently FDA-listed.

NDC 63187-0723-30
🏷️ FDA NDC (as labeled) 63187-723-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.0827/unit — full pricing hub ↓
Product page 63187-0723-00 Also comes in: 6 tablets 63187-723-06 10 tablets 63187-723-10 60 tablets 63187-723-60 90 tablets 63187-723-90 100 tablets 63187-723-00
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) 63187-723-30
Product NDC 63187-723
11-digit billing NDC 63187072330
RxCUI 310273
UNII 5QZO15J2Z8
UPC 0363187723101
Application # ANDA078916
SPL Set ID 9baf2596-b771-4bae-a03c-d3af6716821d
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 2016-01-29
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 49200030000320
GPI class 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
Quick answers
  • GSN (GCN sequence number): 011677
  • GCN: 46430
  • GPI-14 (Medi-Span): 49200030000320
  • HICL (First Databank): 004521
  • AHFS class code: 04:92.00.00
  • RxCUI (RxNorm): 310273
Why two NDCs? The FDA registers this code as 63187-723-30 — 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 → 63187-0723-30. 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 20 MG TABLET Ingredient Famotidine
📗 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 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 · Q2 2026 $0.0827 $2.48 / 30 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0723-00 63187-723-00 Main listing 100 TABLET in 1 BOTTLE 2016-06-01 — Active
63187-0723-06 63187-723-06 6 TABLET in 1 BOTTLE 2019-09-01 — Active
63187-0723-10 63187-723-10 10 TABLET in 1 BOTTLE 2016-11-01 — Active
63187-0723-30 You're viewing this 30 TABLET in 1 BOTTLE 2016-06-01 — Active
63187-0723-60 63187-723-60 60 TABLET in 1 BOTTLE 2016-06-01 — Active
63187-0723-90 63187-723-90 90 TABLET in 1 BOTTLE 2016-06-01 — Active

You're viewing one of 6 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 bottle.
How does this package differ from NDC 63187-0723-06?
Both are Famotidine 20 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 63187-0723-06 is the 6 tablets package.
What NDC number is used to bill for this package of Famotidine 20 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Famotidine 20 mg 00172-5728-60 Teva 100 tablets $0.029 AB Availability likely —
Famotidine 20 mg 00904-7193-06 Major 1 tablet $0.029 AB Availability likely —
Famotidine 20 mg 31722-0017-01 Camber 100 tablets $0.029 AB Availability likely —
Famotidine 20 mg 50268-0299-15 AvPAK 1 tablet $0.029 AB Availability likely —
Famotidine 20 mg 55111-0119-01 Dr.Reddy's 100 tablets $0.029 AB Availability likely —
Famotidine 20 mg 60687-0595-01 American 1 tablet $0.029 AB Availability likely —
Famotidine 20 mg 61442-0121-01 Carlsbad 2400 tablets $0.029 AB Availability likely —
famotidine 20 mg 62135-0807-90 Chartwell 90 tablets $0.029 AB Availability likely —
Famotidine 20 mg 64980-0623-01 Rising 100 tablets $0.029 AB Availability likely —
Famotidine 20 mg 65862-0859-01 Aurobindo 100 tablets $0.029 — Availability likely —
Famotidine 20 mg 67877-0842-01 Ascend 100 tablets $0.029 AB Availability likely —
Famotidine 20 mg 68001-0397-00 BluePoint 100 tablets $0.029 AB Availability likely —
Famotidine 20 mg 68645-0594-59 Legacy 60 tablets $0.029 AB Availability likely —
Famotidine 20 mg 69367-0400-10 Westminster 1000 tablets $0.029 AB Availability likely —
Famotidine 20 mg 70710-1683-00 Zydus 1000 tablets $0.029 AB Availability likely —
Famotidine 20 mg 70756-0051-11 Lifestar 100 tablets $0.029 AB Availability likely —
Famotidine 20 mg 72205-0145-05 Novadoz 500 tablets $0.029 AB Availability likely —
Good Sense Acid Reducer 20 mg 00113-0194-02 L. 1 tablet $0.138 — Availability likely —
Rugby Famotidine 20 mg 00536-1298-01 Rugby 100 tablets $0.138 — Availability likely —
Major Heartburn Relief Maximum Strength 20 mg 00904-5780-17 Major 1 tablet $0.138 — Availability likely —
Famotidine 20 mg 46122-0737-63 Amerisource 25 tablets $0.138 — Availability likely —
Famotidine 20 mg 68094-0054-65 Precision 10 tablets $0.138 — Availability likely —
famotidine 20 mg 69230-0327-01 Camber 100 tablets $0.138 — Availability likely —
Famotidine 20 mg 70000-0049-01 LEADER/ 25 tablets $0.138 — Availability likely —
Leader Acid Reducer 20 mg 70000-0654-01 Cardinal 50 tablets $0.138 — Availability likely —
Famotidine 20 mg 70000-0710-01 LEADER/ 200 tablets $0.138 — Availability likely —
foster and thrive acid reducer 20 mg 70677-1101-01 Strategic 1 tablet $0.138 — Availability likely —
famotidine 20 mg 83324-0008-50 CHAIN 50 tablets $0.138 — Availability likely —
Famotidine 20 mg 83324-0116-25 Chain 25 tablets $0.138 — Availability likely —
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 — — Discontinued —
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 mgthis 63187-0723-30 Proficient 30 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

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 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 Yellow
ShapeRound
ImprintL113;20
Size6 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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.

10 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

LabelerProficient Rx LP
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA078916 (ANDA)
Labeler code63187
First marketedJan 2016
Product typeHuman Prescription Drug
Portfolio1,729 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 ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 203 words ▾

INDICATIONS AND USAGE Famotidine is indicated in: 1. Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks.

Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.

Controlled studies in adults have not extended beyond one year. 3. Short-term treatment of active benign gastric ulcer.

Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. 4.

Short-term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short-term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ). Famotidine is also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ).

5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ) .

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Duodenal Ulcer Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime. Benign Gastric Ulcer Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime. Gastroesophageal Reflux Disease (GERD) The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks.

The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ). Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD) See PRECAUTIONS , Pediatric Patients <1 year of age. The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age.

Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied. Dosage for Pediatric Patients 1 to 16 years of age See PRECAUTIONS , Pediatric Patients 1 to 16 years of age.

The studies described in PRECAUTIONS, Pediatric Patients 1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age: Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day. Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy.

Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations. Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient.

The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated.

Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome. Concomitant Use of Antacids Antacids may be given concomitantly if needed. Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased.

For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficienc… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 37 words ▾

CONTRAINDICATIONS Hypersensitivity to any component of these products. Cross sensitivity in this class of compounds has been observed. Therefore, famotidine should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The adverse reactions listed below have been reported during domestic and international clinical trials in approximately 2500 patients. In those controlled clinical trials in which famotidine Tablets were compared to placebo, the incidence of adverse experiences in the group which received famotidine Tablets, 40 mg at bedtime, was similar to that in the placebo group. The following adverse reactions have been reported to occur in more than 1% of patients on therapy with famotidine in controlled clinical trials, and may be causally related to the drug: headache (4.7%), dizziness (1.3%), constipation (1.2%) and diarrhea (1.7%).

The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with Famotidine has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity: Body as a Whole: fever, asthenia, fatigue Cardiovascular: arrhythmia, AV block, palpitation.

Prolonged QT interval, in patients with impaired renal function, has been reported very rarely. Gastrointestinal: cholestatic jaundice, hepatitis, liver enzyme abnormalities, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic: rare cases of agranulocytosis, pancytopenia, leukopenia, thrombocytopenia Hypersensitivity: anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival injection Musculoskeletal: musculoskeletal pain including muscle cramps, arthralgia Nervous System/Psychiatric : grand mal seizure; psychic disturbances, which were reversible in cases for which follow-up was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; paresthesia; insomnia; somnolence.

Convulsions, in patients with impaired renal function, have been reported very rarely. Respiratory: bronchospasm, interstitial pneumonia Skin: toxic epidermal necrolysis / Stevens Johnson syndrome (very rare), alopecia, acne, pruritus, dry skin, flushing Special Senses: tinnitus, taste disorder Other: rare cases of impotence and rare cases of gynecomastia have been reported; however, in controlled clinical trials, the incidences were not greater than those seen with placebo. Pediatric Patients In a clinical study in 35 pediatric patients <1 year of age with GERD symptoms [e.g., vomiting (spitting up), irritability (fussing)], agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued.

🔄 Drug Interactions 70 words ▾

Drug Interactions No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine.

Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.

🤰 Pregnancy 125 words ▾

Pregnancy Pregnancy Category B 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 I.V. 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 (250 times the usual human dose) 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.

🧓 Geriatric Use 168 words ▾

Geriatric Use Of the 4,966 subjects in clinical studies who were treated with famotidine, 488 subjects (9.8%) were 65 and older, and 88 subjects (1.7%) were greater than 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, greater sensitivity of some older individuals cannot be ruled out.

No dosage adjustment is required based on age (see CLINICAL PHARMACOLOGY IN ADULTS , Pharmacokinetics ). This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Dosage adjustment in the case of moderate or severe renal impairment is necessary (see PRECAUTIONS , Patients with Moderate or Severe Renal Insufficiency and DOSAGE AND ADMINISTRATION , Dosage Adjustment forPatients with Moderate or Severe Renal Insufficiency ).

🆘 Overdosage 189 words ▾

OVERDOSAGE The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see ADVERSE REACTIONS ). Oral doses of up to 640 mg/day have been given to adult patients with pathological hypersecretory conditions with no serious adverse effects. 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. The oral LD 50 of famotidine in male and female rats and mice was greater than 3000 mg/kg and the minimum lethal acute oral dose in dogs exceeded 2000 mg/kg. Famotidine did not produce overt effects at high oral doses in mice, rats, cats and dogs, but induced significant anorexia and growth depression in rabbits starting with 200 mg/kg/day orally.

The intravenous LD 50 of famotidine for mice and rats ranged from 254 to 563 mg/kg and the minimum lethal single I.V. dose in dogs was approximately 300 mg/kg. Signs of acute intoxication in I.V. treated dogs were emesis, restlessness, pallor of mucous membranes or redness of mouth and ears, hypotension, tachycardia and collapse.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY IN ADULTS GI Effects Famotidine is a competitive inhibitor of histamine 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.

In normal volunteers and hypersecretors, famotidine inhibited basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration, 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 and 40 mg was 10 to 12 hours.

Single evening oral doses of 20 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 and 40 mg of famotidine to mean values of 5 and 6.4, respectively.

When famotidine was given after breakfast, the basal daytime interdigestive pH at 3 and 8 hours after 20 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.

Other Effects Systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine systems were not noted in clinical pharmacology studies. Also, no antiandrogenic effects were noted. (See ADVERSE REACTIONS .) Serum hormone levels, including prolactin, cortisol, thyroxine (T 4 ), and testosterone, were not altered after treatment with famotidine.

Pharmacokinetics 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.

Famotidine undergoes minimal first-pass metabolism. After oral doses, peak plasma levels occur in 1 to 3 hours. Plasma levels after multiple doses are similar to those after single doses.

Fifteen to 20% of famotidine in plasma is protein bound. Famotidine has an elimination half-life of 2.5 to 3.5 hours. Famotidine is eliminated by renal (65 to 70%) and metabolic (30 to 35%) routes.

Renal clearance is 250 to 450 mL/min, indicating some tubular excretion. Twenty-five to 30% of an oral dose and 65 to 70% of an intravenous dose are recovered in the urine as unchanged compound. The only metabolite identified in man is the S-oxide.

There is a close relationship between creatinine clearance values and the elimination half-life of famotidine. In patients with severe renal insufficiency, i.e., creatinine clearance less than 10 mL/min, the elimination half-life of famotidine may exceed 20 hours and adjustment of dose or dosing intervals in moderate and severe renal insufficiency may be necessary (see PRECAUTIONS , DOSAGE AND ADMINISTRATION ). In elderly patients, there are no clinically significant age-related changes in the pharmacokinetics of famotidine.

However, in elderly patients with decreased renal function, the clearance of the drug may be decreased (see PRECAUTIONS , Geriatric Use ). Clinical Studies Duodenal Ulcer In a U.S. multicenter, double-blind study in outpatients with endoscopically confirmed duodenal ulcer, orally administered famotidine was compared to placebo. As shown in Table 1, 70% of… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 132 words ▾

HOW SUPPLIED Famotidine Tablets, USP, 20 mg, are yellow colored, circular, biconvex film-coated tablets embossed with 'L113'on one side and '20' on the other side. NDC 63187-723-06 bottles of 6 NDC 63187-723-10 bottles of 10 NDC 63187-723-30 bottles of 30.. NDC 63187-723-60 bottles of 60.

NDC 63187-723-90 bottles of 90. NDC 63187-723-00 bottles of 100. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Preserve in well-closed, light-resistant containers. Call your doctor for medical advice about side effects. You may report side effects to Alembic Pharmaceuticals Limited at 1-866 210 9797 or FDA at 1-800-FDA-1088.

Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 USA Made in India. Revised: 10/2015

📋 Description 122 words ▾

DESCRIPTION The active ingredient in famotidine tablets, USP is a histamine H 2 -receptor antagonist. Famotidine is N '-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl] thio]propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.43.

Its structural formula is: Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Each tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide.

Structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Symptomatic response to therapy with famotidine does not preclude the presence of gastric malignancy. Patients with Moderate or Severe Renal Insufficiency Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, longer intervals between doses or lower doses may need to be used in patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency to adjust for the longer elimination half life of famotidine (see CLINICAL PHARMACOLOGY IN ADULTS and DOSAGE AND ADMINISTRATION ).

Prolonged QT interval has been reported very rarely in patients with impaired renal function whose dose/dosing interval of famotidine may not have been adjusted appropriately. Drug Interactions No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system.

Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found. Carcinogenesis, Mutagenesis, Impairment of Fertility In a 106-week study in rats and a 92-week study in mice given oral doses of up to 2000 mg/kg/day (approximately 2500 times the recommended human dose for active duodenal ulcer), 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 or intravenous doses of up to 200 mg/kg/day, fertility and reproductive performance were not affected.

Pregnancy Pregnancy Category B 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 I.V. 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 (250 times the usual human dose) 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. Nursing Mothers Studies performed in lactating rats have shown that famotidine is secreted into breast milk.

Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of at least 600 times the usual human dose. Famotidine is detectable in human milk. Because of the potential for serious adverse reactions in nursing infants from famotidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Patients <1 year of age Use of famotidine in pediatric patients <1 year of age is supported by evidence from adequate and well-controlled studies of famotidine in adults, and by the following studies in pediatric patients <1 year of age. Two pharmacokinetic studies in pediatric patients <1 year of age (N=48) demonstrated that clearance of famotidine in patients >3 months to 1 year of age is similar to that seen in older pediatric patients (1 to 5 years of age) and adults. In contrast, pediatric patients 0 to 3 months of age had famotidine clearance values that were 2- to 4-fold less than those in… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers ~3 min read ▾

Nursing Mothers Studies performed in lactating rats have shown that famotidine is secreted into breast milk. Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of at least 600 times the usual human dose. Famotidine is detectable in human milk.

Because of the potential for serious adverse reactions in nursing infants from famotidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Patients <1 year of age Use of famotidine in pediatric patients <1 year of age is supported by evidence from adequate and well-controlled studies of famotidine in adults, and by the following studies in pediatric patients <1 year of age. Two pharmacokinetic studies in pediatric patients <1 year of age (N=48) demonstrated that clearance of famotidine in patients >3 months to 1 year of age is similar to that seen in older pediatric patients (1 to 5 years of age) and adults.

In contrast, pediatric patients 0 to 3 months of age had famotidine clearance values that were 2- to 4-fold less than those in older pediatric patients and adults. These studies also show that the mean bioavailability in pediatric patients <1 year of age after oral dosing is similar to older pediatric patients and adults. Pharmacodynamic data in pediatric patients 0 to 3 months of age suggest that the duration of acid suppression is longer compared with older pediatric patients, consistent with the longer famotidine half-life in pediatric patients 0 to 3 months of age.

(See CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS , Pharmacokinetics and Pharmacodynamics .) In a double-blinded, randomized, treatment-withdrawal study, 35 pediatric patients <1 year of age who were diagnosed as having gastroesophageal reflux disease were treated for up to 4 weeks with famotidine oral suspension (0.5 mg/kg/dose or 1 mg/kg/dose). Although an intravenous famotidine formulation was available, no patients were treated with intravenous famotidine in this study. Also, caregivers were instructed to provide conservative treatment including thickened feedings.

Enrolled patients were diagnosed primarily by history of vomiting (spitting up) and irritability (fussiness). The famotidine dosing regimen was once daily for patients <3 months of age and twice daily for patients ≥3 months of age. After 4 weeks of treatment, patients were randomly withdrawn from the treatment and followed an additional 4 weeks for adverse events and symptomatology.

Patients were evaluated for vomiting (spitting up), irritability (fussiness) and global assessments of improvement. The study patients ranged in age at entry from 1.3 to 10.5 months (mean 5.6 ± 2.9 months), 57% were female, 91% were white and 6% were black. Most patients (27/35) continued into the treatment-withdrawal phase of the study.

Two patients discontinued famotidine due to adverse events. Most patients improved during the initial treatment phase of the study. Results of the treatment-withdrawal phase were difficult to interpret because of small numbers of patients.

Of the 35 patients enrolled in the study, agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued; agitation was not observed in patients on placebo (see ADVERSE REACTIONS , Pediatric Patients ). These studies suggest that a starting dose of 0.5 mg/kg/dose of famotidine oral suspension may be of benefit for the treatment of GERD for up to 4 weeks once daily in patients <3 months of age and twice daily in patients 3 months to <1 year of age; the safety and benefit of famotidine treatment beyond 4 weeks have not been established.

Famotidine should be considered for the treatment of GERD only if conservative measures (e.g., thickened feedings) are used concurrently and if the potential benefit outweighs the risk. Pediatric Patients 1 to 16 years of age Use of famotidine in pediatric patients 1 to 16 years… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS Pharmacokinetics Table 6 presents pharmacokinetic data from clinical trials and a published study in pediatric patients (<1 year of age; N=27) given famotidine I.V. 0.5 mg/kg and from published studies of small numbers of pediatric patients (1 to 15 years of age) given famotidine intravenously. Areas under the curve (AUCs) are normalized to a dose of 0.5 mg/kg I.V. for pediatric patients 1 to 15 years of age and compared with an extrapolated 40 mg intravenous dose in adults (extrapolation based on results obtained with a 20 mg I.V. adult dose).

Table 6 Pharmacokinetic Parameters a of Intravenous Famotidine Age (N= number of patients) Area Under the Curve (AUC)(ng-hr/mL) Total Clearance(Cl) (L/hr/kg) Volume of Distribution (V d ) (L/kg) Elimination Half-life (T 1/2 ) (hours) 0 to 1 months c (N=10) NA 0.13±0.06 1.4±0.4 10.5±5.4 0 to 3 months d (N=6) 2688±847 0.21±0.06 1.8±0.3 8.1±3.5 >3 to 12 months d (N=11) 1160±474 0.49±0.17 2.3±0.7 4.5±1.1 1 to 11 yrs (N=20) 1089±834 0.54±0.34 2.07±1.49 3.38±2.60 11 to 15 yrs (N=6) 1140±320 0.48±0.14 1.5±0.4 2.3±0.4 Adult (N=16) 1726 b 0.39±0.14 1.3±0.2 2.83±0.99 a Values are presented as means ± SD unless indicated otherwise. b Mean value only. c Single center study. d Multicenter study.

Plasma clearance is reduced and elimination half-life is prolonged in pediatric patients 0 to 3 months of age compared to older pediatric patients. The pharmacokinetic parameters for pediatric patients, ages >3 months-15 years, are comparable to those obtained for adults. Bioavailability studies of 8 pediatric patients (11 to 15 years of age) showed a mean oral bioavailability of 0.5 compared to adult values of 0.42 to 0.49.

Oral doses of 0.5 mg/kg achieved AUCs of 645 ± 249 ng-hr/mL and 580 ± 60 ng-hr/mL in pediatric patients <1 year of age (N=5) and in pediatric patients 11 to 15 years of age, respectively, compared to 482 ± 181 ng-hr/mL in adults treated with 40 mg orally. Pharmacodynamics Pharmacodynamics of famotidine 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 one study of adults (Table 7).

Table 7 Pharmacodynamics of famotidine using the sigmoid E max model Pediatric Patients EC 50 (ng/mL)* 26 ± 13 Data from one study a) healthy adult subjects 26.5 ± 10.3 b) adult patients with upper GI bleeding 18.7 ± 10.8 * Serum concentration of famotidine associated with 50% maximum gastric acid reduction. Values are presented as means ± SD. Five published studies (Table 8) examined the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients.

While each study had a different design, acid suppression data over time are summarized as follows: Table 8 Dosage Route Effect a Number of Patients (age range) 0.5 mg/kg, single dose I.V. gastric pH >4 for 19.5 hours(17.3, 21.8) c 11 (5 to 19 days) 0.3 mg/kg, single dose I.V. gastric pH >3.5 for 8.7 ± 4.7 b hours 6 (2 to 7 years) 0.4 to 0.8 mg/kg I.V. gastric pH >4 for 6 to 9 hours 18 (2 to 69 months) 0.5 mg/kg, single dose I.V. a >2 pH unit increase above baseline in gastric pH for >8 hours 9 (2 to 13 years) 0.5 mg/kg b.i.d I.V. gastric pH >5 for 13.5 ± 1.8 b hours 4 (6 to 15 years) 0.5 mg/kg b.i.d oral gastric pH >5 for 5 ± 1.1 b hours 4 (11 to 15 years) a values reported in published literature. b Means ± SD c Mean (95% confidence interval).

The duration of effect of famotidine I.V. 0.5 mg/kg on gastric pH and acid suppression was shown in one study to be longer in pediatric patients <1 month of age than in older pediatric patients. This longer duration of gastric acid suppression is consistent with the decreased clearance in pediatric patients <3 months of age (see Table 6).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 124 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility In a 106-week study in rats and a 92-week study in mice given oral doses of up to 2000 mg/kg/day (approximately 2500 times the recommended human dose for active duodenal ulcer), 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 or intravenous doses of up to 200 mg/kg/day, fertility and reproductive performance were not affected.

📄 Package Label / Principal Display Panel 26 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-20 mg Famotidine Tablets USP 20 mg (10 Tablets in 1 Bottle) Each Film Coated Tablet Contains: Famotidine USP 20 mg 63187-723-10 63187-723-10

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

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Proficient Rx LP. 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 5 other package presentations of this same product, including 6 tablets (63187-0723-06), 10 tablets (63187-0723-10), 60 tablets (63187-0723-60). 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?
Proficient Rx LP 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.
← 63187-0721-15 · Proficient 63187-0726-30 · Proficient →
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.