Search by Drug Name or NDC

NDC 71205-0637-30 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 Proficient Rx LP. 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: 71205-0637-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Famotidine

Product Information

NDC	71205-0637
Product ID	71205-637_ce4deda2-a2d0-47da-9366-a35358dfbcad
Associated GPIs	49200030000310
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	Proficient Rx LP
Pharmaceutical Class	Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA206531
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0637-30 (71205063730)

Pricing Information	N/A
NDC Package Code	71205-637-30
Billing NDC	71205063730
Package	30 TABLET, FILM COATED in 1 BOTTLE (71205-637-30)
Marketing Start Date	2022-02-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 68120de1-fd9a-4f93-b218-d99ed7c5080a 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

•: 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

•: 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 (1-800-222-1222) right away.

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 to 60 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

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

Inactive ingredients

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc and titanium dioxide.

Questions or comments?

call 1-855-274-4122

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

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

Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Label)

NDC 71205-637-30

See New Warnings

*Compare to the Active Ingredient

of Original Strength Pepcid® AC

ORIGINAL STRENGTH

Famotidine

Tablets USP 10 mg

Acid Reducer

Just One Tablet!

Prevents & Relieves Heartburn

Due to Acid Indigestion

30 Tablets

INGREDIENTS AND APPEARANCE

FAMOTIDINE

famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-637(NDC:58602-705)
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND (biconvex)	Size	5mm
Flavor		Imprint Code	CC;58
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-637-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2022
2	NDC:71205-637-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2022
3	NDC:71205-637-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206531	04/26/2016

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-637) , RELABEL(71205-637)

Revised: 6/2022

Document Id: ce4deda2-a2d0-47da-9366-a35358dfbcad

Set id: 68120de1-fd9a-4f93-b218-d99ed7c5080a

Version: 2

Effective Time: 20220601