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NDC 53808-1116-01 MECLIZINE HYDROCHLORIDE 25 mg/1 Details

MECLIZINE HYDROCHLORIDE 25 mg/1

MECLIZINE HYDROCHLORIDE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by DOH CENTRAL PHARMACY. The primary component is MECLIZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.

Related Packages: 53808-1116-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	53808-1116
Product ID	53808-1116_a804d650-9d29-447a-b311-87f1e4b43cab
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MECLIZINE HYDROCHLORIDE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Meclizine Hydrocloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	MECLIZINE HYDROCHLORIDE
Labeler Name	DOH CENTRAL PHARMACY
Pharmaceutical Class	Antiemetic [EPC], Emesis Suppression [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA040659
Listing Certified Through	2023-12-31

Package

Package Images

NDC 53808-1116-01 (53808111601)

Pricing Information	N/A
NDC Package Code	53808-1116-1
Billing NDC	53808111601
Package	30 TABLET in 1 BLISTER PACK (53808-1116-1)
Marketing Start Date	2017-10-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 478bac81-1b81-4c8e-b894-019c5a039b6d Details

DESCRIPTION

Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.

C25H27ClN2• 2HCl•H2O Molecular Weight 481.88

Meclizine hydrochloride tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine hydrochloride tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine hydrochloride tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%).

CLINICAL PHARMACOLOGY

Meclizine hydrochloride is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

Pharmacokinetics

The available pharmacokinetic information for meclizine following oral administration has been summarized from published literature.

Absorption

Meclizine is absorbed after oral administration with maximum plasma concentrations reaching at a median Tmax value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form.

Distribution

Drug distribution characteristics for meclizine in humans are unknown.

Metabolism

The metabolic fate of meclizine in humans is unknown. In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP2D6 was found to be the dominant enzyme for metabolism of meclizine.

The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate- and ultra-rapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.

Elimination

Meclizine has a plasma elimination half-life of about 5-6 hours in humans.

INDICATIONS AND USAGE

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.

CONTRAINDICATIONS

Meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

WARNINGS

Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.

Patients should avoid alcoholic beverages while taking this drug.

Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

PRECAUTIONS

Pediatric Use

Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.

Pregnancy

Pregnancy Category B.

Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when meclizine is administered to a nursing woman.

Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As meclizine undergoes metabolism, hepatic impairment may result in increased systemic exposure of the drug. Treatment with meclizine should be administered with caution in patients with hepatic impairment.

Renal Impairment

The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Due to a potential for drug/metabolite accumulation, meclizine should be administered with caution in patients with renal impairment and in the elderly as renal function generally declines with age.

Drug Interactions

There may be increased CNS depression when meclizine is administered concurrently with other CNS depressants, including alcohol, tranquilizers, and sedatives. (see WARNINGS).

Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore there is a possibility for a drug interaction between meclizine and CYP2D6 inhibitors.

ADVERSE REACTIONS

Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

For the treatment of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 to 100 mg daily, in divided dosage, depending upon clinical response.

HOW SUPPLIED

Meclizine hydrochloride tablets, USP are available in the following strengths:

12.5 mg (Blue, oval shaped tablets, debossed with “TL 122” with score on one side and plain on the other side.)

25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.)

They are supplied by DOH CENTRAL PHARMACY as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
53808-1116-1	25 MG	30 Tablets in a Blister Pack	YELLOW	59746-121

Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

Manufactured By:

Jubilant Cadista Pharmaceuticals Inc.

Salisbury, MD 21801, USA

This Product was Repackaged By:

DOH CENTRAL PHARMACY

104 HAMILTON PARK DR # 2

TALLAHASSEE, FL 32304

USA

PACKAGE LABEL

Label Image for 53808-1116

25mg

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE

meclizine hydrocloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:53808-1116(NDC:59746-121)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	YELLOW	Score	2 pieces
Shape	OVAL	Size	13mm
Flavor		Imprint Code	TL121
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53808-1116-1	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040659	10/26/2017

Labeler - DOH CENTRAL PHARMACY (829348114)

Name	Address	ID/FEI	Business Operations
Establishment
DOH CENTRAL PHARMACY		829348114	repack(53808-1116)

Revised: 1/2019

Document Id: a804d650-9d29-447a-b311-87f1e4b43cab

Set id: 478bac81-1b81-4c8e-b894-019c5a039b6d

Version: 1

Effective Time: 20190118