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NDC 68001-0436-04 Cetirizine Hydrochloride (Allergy) 10 mg/1 Details

Cetirizine Hydrochloride (Allergy) 10 mg/1

Cetirizine Hydrochloride (Allergy) is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by BluePoint Laboratories. The primary component is CETIRIZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 68001-0436-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	68001-0436
Product ID	68001-436_c8455ce1-5b5b-3b17-e053-2995a90a7116
Associated GPIs	41550020100320
GCN Sequence Number	017037
GCN Sequence Number Description	cetirizine HCl TABLET 10 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	49291
HICL Sequence Number	006544
HICL Sequence Number Description	CETIRIZINE HCL
Brand/Generic	Generic
Proprietary Name	Cetirizine Hydrochloride (Allergy)
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetirizine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE 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	ANDA090760
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68001-0436-04 (68001043604)

Pricing Information
NDC Package Code	68001-436-04
Billing NDC	68001043604
Package	1 BOTTLE in 1 CARTON (68001-436-04) / 30 TABLET in 1 BOTTLE
Marketing Start Date	2020-06-19
NDC Exclude Flag	N
Price Per Unit	0.06399
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	CETIRIZINE HCL 10 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 a86fbe45-08db-bddf-e053-2a95a90aa792 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

For 10 mg:

Cetirizine hydrochloride USP 10 mg

Purpose

Antihistamine

Uses

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

runny nose
sneezing
itchy, watery eyes
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 or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

If breast-feeding: not recommended
if pregnant: 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

For 10 mg:

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

store between 20° to 25°C (68° to 77°F)
TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

call 1-855-274-4122

Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 090, India

For BluePoint Laboratories

Made in India

Code: TS/DRUGS/19/1993

Issued 05/2020

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

NDC 68001-436-04

*Compare to the active

ingredient of Zyrtec ®

Allergy Relief

Cetirizine Hydrochloride Tablets USP 10 mg

Antihistamine

Original Prescription Strength

Indoor & Outdoor Allergies

24 Hour Relief of :

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 Tablets

10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

NDC68001436-96

*Compare to the active

ingredient of Zyrtec ®

Allergy Relief

Cetirizine Hydrochloride Tablets USP 10 mg

Antihistamine

Original Prescription Strength

Indoor & Outdoor Allergies

24 Hour Relief of :

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

100 (10x10) Tablets

10 mg each

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (ALLERGY)

cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68001-436
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (White to Off-white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	X;36
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68001-436-96	1 in 1 CARTON	06/19/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:68001-436-04	1 in 1 CARTON	06/19/2020
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:68001-436-97	1 in 1 CARTON	06/19/2020
3		300 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:68001-436-16	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090760	06/19/2020

Labeler - BluePoint Laboratories (985523874)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	analysis(68001-436) , manufacture(68001-436)

Revised: 7/2021

Document Id: c8455ce1-5b5b-3b17-e053-2995a90a7116

Set id: a86fbe45-08db-bddf-e053-2a95a90aa792

Version: 2

Effective Time: 20210729