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NDC 70677-0079-01 Sunmark Fexofenadine Hydrochloride 60 mg/1 Details

Sunmark Fexofenadine Hydrochloride 60 mg/1

Sunmark Fexofenadine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 70677-0079-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	70677-0079
Product ID	70677-0079_134b961a-f1aa-4d4a-919f-e71f336bb581
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	Sunmark Fexofenadine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Fexofenadine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	60
Active Ingredient Units	mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076447
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70677-0079-01 (70677007901)

Pricing Information
NDC Package Code	70677-0079-1
Billing NDC	70677007901
Package	12 BLISTER PACK in 1 CARTON (70677-0079-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2019-08-21
NDC Exclude Flag	N
Price Per Unit	0.18253
Pricing Unit	EA
Effective Date	2022-02-23
NDC Description	SM FEXOFENADINE HCL 60 MG TAB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-03-16

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 7a77fa89-d256-45ad-bbfe-e93305a1c357 Details

Active ingredient (in each tablet)

Fexofenadine HCl 60 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 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

•: do not use if printed blister unit is broken or torn
•: store between 20°-25°C (68°-77°F)
•: protect from excessive moisture
•: this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO ALLEGRA® ALLERGY ACTIVE INGREDIENT

12 HR

fexofenadine hydrochloride Tablets, 60 mg/Antihistamine

NON-DROWSY

Indoor/outdoor allergy relief of sneezing; runny nose; itchy, watery eyes; itchy nose or throat

ALLERGY

Actual Size

GLUTEN FREE

12 TABLETS

INGREDIENTS AND APPEARANCE

SUNMARK FEXOFENADINE HYDROCHLORIDE

fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0079
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (Peach)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	93;7252
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-0079-1	12 in 1 CARTON	08/21/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076447	08/21/2019

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 7/2021

Document Id: 134b961a-f1aa-4d4a-919f-e71f336bb581

Set id: 7a77fa89-d256-45ad-bbfe-e93305a1c357

Version: 3

Effective Time: 20210721