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NDC 57896-0767-06 Famotidine 10 mg/1 Details

Famotidine 10 mg/1

Famotidine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Geri-Care Pharmaceutical Corp. The primary component is FAMOTIDINE.

MedlinePlus Drug Summary

Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.

Related Packages: 57896-0767-06
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Famotidine

Product Information

NDC	57896-0767
Product ID	57896-767_d9cefc55-7646-ce9b-e053-2a95a90aff12
Associated GPIs
GCN Sequence Number	021688
GCN Sequence Number Description	famotidine TABLET 10 MG ORAL
HIC3	Z2D
HIC3 Description	HISTAMINE H2-RECEPTOR INHIBITORS
GCN	46432
HICL Sequence Number	004521
HICL Sequence Number Description	FAMOTIDINE
Brand/Generic	Generic
Proprietary Name	Famotidine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Famotidine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	FAMOTIDINE
Labeler Name	Geri-Care Pharmaceutical Corp
Pharmaceutical Class	Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090283
Listing Certified Through	2023-12-31

Package

Package Images

NDC 57896-0767-06 (57896076706)

Pricing Information	N/A
NDC Package Code	57896-767-06
Billing NDC	57896076706
Package	1 BOTTLE in 1 CARTON (57896-767-06) / 60 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2022-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cff9fcec-35ec-722a-e053-2a95a90ab085 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Famotidine, USP 10 mg

Purpose

Acid reducer

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

Warnings

Allergy alert

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

Do not use

with other acid reducers
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.

Ask a doctor before use if you have

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

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

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

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

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

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 with a glass of water at any time from 15 to60 minutes 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

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

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions?

Call toll-free Monday-Friday 9 am to 5 pm EST at 1-800-540-3765

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

FAMOTIDINE

famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57896-767
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	035
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57896-767-06	1 in 1 CARTON	02/01/2022
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090283	02/01/2022

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 3/2022

Document Id: d9cefc55-7646-ce9b-e053-2a95a90aff12

Set id: cff9fcec-35ec-722a-e053-2a95a90ab085

Version: 2

Effective Time: 20220309