FDA.reportPublic FDA data

Famotidine Tablets

Manufacturer
GLENMARK THERAPEUTICS INC., USA | VKT Pharma Private Limited
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:33:58

Label at a glance#

ProductFamotidine
Active ingredientFAMOTIDINE
Label structure13 sections

Indications and uses

• relieves heartburn associated with acid indigestion and sour stomach • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Dosage and administration

• adults and children 12 years and over: o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. o to prevent symptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn o to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or dr...

Storage and handling

• read the directions and warnings before use • keep the carton. It contains important information. • store at 20°C to 25°C (68°F to 77°F) • protect from moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine, USP 10 mg and 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to famotidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • with other acid reducers

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating, or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1 (800) 222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to prevent symptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
    • to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
    • before eating food or drinking beverages that cause heartburn
    • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°C to 25°C (68°F to 77°F)
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hydroxypropyl Cellulose, Hypromellose, , Macrogol, Magnesium stearate, Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Talc, Triacetin, Titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Do not use if printed foil seal on bottle is broken or missing.

JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

TIPS FOR MANAGING HEARTBURN

􀀁 Do not lie flat or bend over after eating 􀀁 Do not wear tight-fitting clothing around the stomach

􀀁 Do not eat before bedtime 􀀁 Raise the head of your bed 􀀁 Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables 􀀁 Eat slowly and avoid big meals 􀀁 If overweight, lose weight 􀀁 Quit smoking

SPL UNCLASSIFIED SECTION

Distributed by: Glenmark Therapeutics Inc., USA
Elmwood Park, NJ 07407
Made in India
M.L. No.: 02/SKL/AP/2015/F/R

Revision: 07/25

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72657-112-90

Famotidine Tablets, USP 10mg

90 Tablets

carton10mg90
carton10mg90

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72657-113-88

Famotidine Tablets, USP 20mg

85 Tablets

carton20mg85
carton20mg85

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72657-132-01

Famotidine Tablets, USP 20mg

100 Tablets

carton20mg100
carton20mg100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199047famotidine 10 MG Oral TabletPSN4
310273famotidine 20 MG Oral TabletPSN4
199047famotidine 10 MG Oral TabletSCD4
310273famotidine 20 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FAMOTIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372657112901GTIN-13: 0372657112901
EAN-13: 0372657112901
GTIN-12: 372657112901
UPC-A: 372657112901
GTIN storage (14 digits): 00372657112901		carton10mg90.jpg
BarcodeEAN-130372657113885GTIN-13: 0372657113885
EAN-13: 0372657113885
GTIN-12: 372657113885
UPC-A: 372657113885
GTIN storage (14 digits): 00372657113885		carton20mg85.jpg
BarcodeEAN-130372657132015GTIN-13: 0372657132015
EAN-13: 0372657132015
GTIN-12: 372657132015
UPC-A: 372657132015
GTIN storage (14 digits): 00372657132015		carton20mg100.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72657-112-20Famotidine200 in 1 BOTTLETABLET, FILM COATED2004
72657-112-20Famotidine1 in 1 CARTONTABLET, FILM COATED14
72657-112-90Famotidine90 in 1 BOTTLETABLET, FILM COATED904
72657-112-90Famotidine1 in 1 CARTONTABLET, FILM COATED14
72657-113-20Famotidine1 in 1 CARTONTABLET, FILM COATED14
72657-113-20Famotidine200 in 1 BOTTLETABLET, FILM COATED2004
72657-113-88Famotidine85 in 1 BOTTLETABLET, FILM COATED854
72657-113-88Famotidine1 in 1 CARTONTABLET, FILM COATED14
72657-132-01Famotidine100 in 1 BOTTLETABLET, FILM COATED1004
72657-132-01Famotidine1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-112-20EA - Each72657-112b81f7a14-e15e-4fb2-a97d-3bcdaea6714912026-03-17
72657-112-90EA - Each72657-1123271ae8f-f700-4593-a721-bc5e8aff6cdc12026-03-17
72657-113-20EA - Each72657-1136ddef29c-eb34-48e0-a98c-f7efee9fae4512026-03-17
72657-113-88EA - Each72657-113c41bab95-97f7-4d75-87b5-121b0fe8b76412026-03-17
72657-132-01EA - Each72657-13291336b2a-8358-4cb5-b25d-f8b819c145aa12026-03-17

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72657-11272657-112-90, 72657-112-20
72657-11372657-113-88, 72657-113-20
72657-13272657-132-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)5Y0974F5PWIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
TALC7SEV7J4R1UIACT
FAMOTIDINE5QZO15J2Z8ACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)5Y0974F5PWIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
TALC7SEV7J4R1UIACT
FAMOTIDINE5QZO15J2Z8ACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)5Y0974F5PWIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
TALC7SEV7J4R1UIACT
FAMOTIDINE5QZO15J2Z8ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215822-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2022-01-28
A215822-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2022-01-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28c2088c7a36db…
2026-10-15 13:18:302026-09A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28c2088c7a36db…
2026-09-14 22:38:342026-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2884e616aacf4f…
2026-09-14 22:38:342026-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2884e616aacf4f…
2026-08-18 06:07:402026-07A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-284b0b4de00fa7…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEGLENMARK THERAPEUTICS INC., USA95f51f27-d367-4cfd-a15f-7856c9e361fb2026-01-13WarningsExact identifier
ndc (package): 72657-113-20
ndc (package): 72657-132-01
ndc (package): 72657-113-88
ndc (package): 72657-112-90
ndc (package): 72657-112-20
ndc (product): 72657-132
ndc (product): 72657-113
ndc (product): 72657-112
ndc11 (package): 72657013201
ndc11 (package): 72657011388
ndc11 (package): 72657011220
ndc11 (package): 72657011290
ndc11 (package): 72657011320
spl id: 5502899d-30bd-4954-8aae-9ab1c034f65f
spl set id: 95f51f27-d367-4cfd-a15f-7856c9e361fb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.