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NDC 68001-0439-00 Fexofenadine hydrochloride 60 mg/1 Details

Fexofenadine hydrochloride 60 mg/1

Fexofenadine hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by BluePoint Laboratories. 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: 68001-0439-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	68001-0439
Product ID	68001-439_bd31cd71-9281-7667-e053-2995a90a4ac0
Associated GPIs	41550024100320
GCN Sequence Number	031689
GCN Sequence Number Description	fexofenadine HCl TABLET 60 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	46593
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
Route	ORAL
Active Ingredient Strength	60
Active Ingredient Units	mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE
Labeler Name	BluePoint Laboratories
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076502
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68001-0439-00 (68001043900)

Pricing Information
NDC Package Code	68001-439-00
Billing NDC	68001043900
Package	1 BOTTLE in 1 CARTON (68001-439-00) / 100 TABLET in 1 BOTTLE
Marketing Start Date	2020-06-19
NDC Exclude Flag	N
Price Per Unit	0.17144
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	FEXOFENADINE HCL 60 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 a86aebd0-937e-5d73-e053-2995a90a656a Details

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(s)

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 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 printed foil inner seal on bottle is torn or missing
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

Call 1-888-375-3784

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

PRINCIPAL DISPLAY PANEL

Fexofenadine HCL Tablets, 60 mg Carton:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE

fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68001-439
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	4mm
Flavor		Imprint Code	193;R
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68001-439-00	1 in 1 CARTON	06/19/2020
1		100 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	ANDA076502	06/19/2020

FEXOFENADINE HYDROCHLORIDE

fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68001-440
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	194;R
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68001-440-00	1 in 1 CARTON	06/19/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:68001-440-04	1 in 1 CARTON	06/19/2020
2		30 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	ANDA076502	06/19/2020

Labeler - BluePoint Laboratories (985523874)

Name	Address	ID/FEI	Business Operations
Establishment
DR. REDDY'S LABORATORIES LIMITED		860037244	manufacture(68001-439, 68001-440) , analysis(68001-439, 68001-440)

Name	Address	ID/FEI	Business Operations
Establishment
Dr. Reddy's Laboratories Limited (FTO III)		918608162	analysis(68001-439, 68001-440) , manufacture(68001-439, 68001-440)

Revised: 3/2021

Document Id: bd31cd71-9281-7667-e053-2995a90a4ac0

Set id: a86aebd0-937e-5d73-e053-2995a90a656a

Version: 2

Effective Time: 20210312

Search by Drug Name or NDC

NDC 68001-0439-00 Fexofenadine hydrochloride 60 mg/1 Details

Fexofenadine hydrochloride 60 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68001-0439-00 (68001043900)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a86aebd0-937e-5d73-e053-2995a90a656a Details

Active ingredient(s)

Purpose

Use(s)

Warnings

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions?

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

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