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NDC 58602-0705-15 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 Aurohealth LLC. 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: 58602-0705-15
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Famotidine

Product Information

NDC	58602-0705
Product ID	58602-705_eae812ef-42f7-4f61-8b94-fea12e621da0
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	Aurohealth LLC
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 58602-0705-15 (58602070515)

Pricing Information	N/A
NDC Package Code	58602-705-15
Billing NDC	58602070515
Package	1 BOTTLE in 1 CARTON (58602-705-15) / 60 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2016-04-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 756c7234-6a63-4b1b-be36-2b1ed09e67a0 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

279 Princeton-Hightstown Road,

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets Container Label)

AUROHEALTH

NDC 58602-705-19

ORIGINAL STRENGTH

Famotidine

Tablets USP 10 mg

Acid Reducer

Just One Tablet!

Prevents & Relieves Heartburn

Due to Acid Indigestion

90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets Container Carton Label)

AUROHEALTH

NDC 58602-705-19

*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

90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg, Blister Carton 30 Tablets

AUROHEALTH

NDC 58602-705-09

*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: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:58602-705-15	1 in 1 CARTON	04/26/2016
1		60 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:58602-705-19	1 in 1 CARTON	04/26/2016
2		90 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:58602-705-84	1 in 1 CARTON	05/13/2019
3		30 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:58602-705-09	3 in 1 CARTON	04/26/2016
4	NDC:58602-705-03	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:58602-705-12	4 in 1 CARTON	04/26/2016
5	NDC:58602-705-03	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:58602-705-93	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2016
7	NDC:58602-705-14	1 in 1 CARTON	12/21/2019
7		50 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:58602-705-34	1 in 1 CARTON	07/22/2020
8		200 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:58602-705-39	1 in 1 CARTON	07/22/2020
9		365 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC:58602-705-44	1 in 1 CARTON	07/22/2020
10		400 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC:58602-705-40	1 in 1 CARTON	07/22/2020
11		500 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC:58602-705-88	1 in 1 CARTON	07/22/2020
12		750 in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC:58602-705-41	1 in 1 CARTON	09/04/2020
13		1000 in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC:58602-705-32	1 in 1 CARTON	02/18/2022
14		180 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	ANDA206531	04/26/2016

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
APL HEALTHCARE LIMITED		650844777	ANALYSIS(58602-705) , MANUFACTURE(58602-705)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-705) , MANUFACTURE(58602-705)

Revised: 4/2022

Document Id: eae812ef-42f7-4f61-8b94-fea12e621da0

Set id: 756c7234-6a63-4b1b-be36-2b1ed09e67a0

Version: 12

Effective Time: 20220428