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NDC 51660-0998-30 FEXOFENADINE HYDROCHLORIDE 180 mg/1 Details

FEXOFENADINE HYDROCHLORIDE 180 mg/1

FEXOFENADINE HYDROCHLORIDE is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by OHM LABORATORIES INC.. The primary component is FEXOFENADINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth in adults and children 2 years of age and older. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), including itching and rash in adults and children 6 months of age and older. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.

Related Packages: 51660-0998-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	51660-0998
Product ID	51660-998_091c0633-b5d5-462a-8aa0-36ae245dbbbc
Associated GPIs
GCN Sequence Number	033716
GCN Sequence Number Description	fexofenadine HCl TABLET 180 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	46594
HICL Sequence Number	011595
HICL Sequence Number Description	FEXOFENADINE HCL
Brand/Generic	Generic
Proprietary Name	FEXOFENADINE HYDROCHLORIDE
Proprietary Name Suffix	n/a
Non-Proprietary Name	FEXOFENADINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE
Labeler Name	OHM LABORATORIES INC.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA091567
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51660-0998-30 (51660099830)

Pricing Information
NDC Package Code	51660-998-30
Billing NDC	51660099830
Package	1 BOTTLE in 1 CARTON (51660-998-30) / 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2022-04-29
NDC Exclude Flag	N
Price Per Unit	0.25711
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	FEXOFENADINE HCL 180 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 1a1afa95-570d-456e-b436-a0fcfaf68517 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl, USP 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed
do not take at the same time as aluminum or magnesium antacids
do not take with fruit juices (see Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

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 of age and over	take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Other information

safety sealed: do not use if carton is opened or if inner safety seal is torn or missing
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions or comments?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

SPL UNCLASSIFIED SECTION

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

MADE IN INDIA

PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

†Compare To

the active ingredient of

Allegra® Allergy

NDC 51660-998-30

NDC 51660-998-55

NON-DROWSY

Fexofenadine Hydrochloride

Tablets, USP 180 mg

Antihistamine

Indoor and Outdoor Allergies

ALLERGY

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

ohm®

30 Tablets

DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH

"SEALED for YOUR PROTECTION" IS TORN OR MISSING

Principal Display Panel - 180 mg Tablet Bottle Carton

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE

fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-998
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	545
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51660-998-30	1 in 1 CARTON	04/29/2022
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51660-998-55	1 in 1 CARTON	04/29/2022
2		150 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	ANDA091567	04/29/2022

Labeler - OHM LABORATORIES INC. (184769029)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Pharmaceutical Industries Limited		650445203	MANUFACTURE(51660-998)

Revised: 4/2022

Document Id: 091c0633-b5d5-462a-8aa0-36ae245dbbbc

Set id: 1a1afa95-570d-456e-b436-a0fcfaf68517

Version: 1

Effective Time: 20220426

Search by Drug Name or NDC

NDC 51660-0998-30 FEXOFENADINE HYDROCHLORIDE 180 mg/1 Details

FEXOFENADINE HYDROCHLORIDE 180 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51660-0998-30 (51660099830)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1a1afa95-570d-456e-b436-a0fcfaf68517 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Uses

Warnings

When using this product

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

INGREDIENTS AND APPEARANCE

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