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NDC 69230-0327-05 famotidine 20 mg/1 Details

famotidine 20 mg/1

famotidine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Camber Consumer Care Inc. 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: 69230-0327-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Famotidine

Product Information

NDC	69230-0327
Product ID	69230-327_eabd2ff8-a7d9-2ac4-e053-2995a90a3b40
Associated GPIs
GCN Sequence Number	011677
GCN Sequence Number Description	famotidine TABLET 20 MG ORAL
HIC3	Z2D
HIC3 Description	HISTAMINE H2-RECEPTOR INHIBITORS
GCN	46430
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	20
Active Ingredient Units	mg/1
Substance Name	FAMOTIDINE
Labeler Name	Camber Consumer Care Inc
Pharmaceutical Class	Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA215766
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69230-0327-05 (69230032705)

Pricing Information	N/A
NDC Package Code	69230-327-05
Billing NDC	69230032705
Package	1 BOTTLE in 1 CARTON (69230-327-05) / 500 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2021-11-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ebe3ca30-df25-4c56-8935-414a3431b5b9 Details

Active ingredient (in each tablet)

Famotidine USP 10 mg and 20 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 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.

10 mg:

• 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

20 mg:

• to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 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

corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and film coating contains carnauba wax, hydroxypropyl cellulose, hypromellose, talc, titanium dioxide; and additionally 20 mg contains iron oxide red and iron oxide yellow.

Questions or comments?

1-866-495-1995

PRINCIPAL DISPLAY PANEL

Famotidine Tablets USP 10 mg - 30s container label

Famotidine Tablets USP 10 mg - 30s container carton label

Famotidine Tablets USP 10 mg - 10 (1x10) blister carton label

Famotidine Tablets USP 20 mg - 30s container label

Famotidine Tablets USP 20 mg - 30s container carton label

Famotidine Tablets USP 20 mg - 10 (1x10) blister carton label

INGREDIENTS AND APPEARANCE

FAMOTIDINE

famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69230-326
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
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T;10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69230-326-30	1 in 1 CARTON	11/08/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:69230-326-60	1 in 1 CARTON	11/08/2021
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:69230-326-01	1 in 1 CARTON	11/08/2021
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:69230-326-05	1 in 1 CARTON	11/08/2021
4		500 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:69230-326-10	1 in 1 CARTON	11/08/2021
5		1000 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	ANDA215766	11/08/2021