NDC 70518-2304 Meclizine Hydrochloride

Meclizine Hydrochloride

NDC Product Code 70518-2304

NDC Code: 70518-2304

Proprietary Name: Meclizine Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Meclizine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT)
Shape: OVAL (C48345)
Size(s):
13 MM
Imprint(s):
AN;442
Score: 1

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-2304-0

Package Description: 90 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Meclizine Hydrochloride with NDC 70518-2304 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Meclizine Hydrochloride is meclizine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Meclizine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MECLIZINE HYDROCHLORIDE 25 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • TALC (UNII: 7SEV7J4R1U)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Antiemetic - [EPC] (Established Pharmacologic Class)
  • Emesis Suppression - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA201451 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-09-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Meclizine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

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

The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response.

2.2 Administration Instructions

TabletsMeclizine hydrochloride tablets must be swallowed whole.

3 Dosage Forms And Strengths

  • 12.5 mg: light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. 25 mg: light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. 50 mg: white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side.

4 Contraindications

Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients


[see


Adverse Reactions (6) and


Description (11)]


.

5.1 Drowsiness

Since drowsiness may occur with use of meclizine hydrochloride, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking meclizine hydrochloride


[see


Drug Interactions (7.1)].

5.2 Concurrent Medical Conditions

Because of its potential anticholinergic action, meclizine hydrochloride should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

6 Adverse Reactions

The following adverse reactions associated with the use of meclizine hydrochloride were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported.

7.1 Cns Depressants

There may be increased CNS depression when meclizine hydrochloride is administered concurrently with other CNS depressants, including alcohol


[see


Warnings and Precautions (5.1)]


.

7.2 Cyp2d6 Inhibitors

Based on


in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore, there is a possibility for a drug interaction between meclizine hydrochloride and CYP2D6 inhibitors. Therefore, monitor for adverse reactions and clinical effect accordingly.

8.1 Pregnancy

Risk SummaryData from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. DataHuman Data Epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects. Animal Data In a published study, oral administration of meclizine (25 mg/kg to 250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations. These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m


2) basis.

8.2 Lactation

Risk SummaryThere are no data on the presence of meclizine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for meclizine hydrochloride and any potential adverse effects on the breastfed infant from meclizine hydrochloride or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Hepatic Impairment

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

8.7 Renal Impairment

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

8.8 Genetic Cyp2d6 Polymorphism

The genetic polymorphism of CYP2D6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. Therefore, when meclizine hydrochloride is administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

11 Description

Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula:Chemically, meclizine hydrochloride  is 1-(


p-chloro-α-phenylbenzyl)-4-(


m-methylbenzyl) piperazine dihydrochloride monohydrate.


Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg tablets also contain D&C Yellow #10 Aluminum Lake.Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base.Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. Each meclizine hydrochloride 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 mg of meclizine free base.

12.1 Mechanism Of Action

The precise mechanism by which meclizine exerts its therapeutic effect is unknown but is presumed to involve antagonism of the histamine H1 receptor.

12.2 Pharmacodynamics

There are no relevant pharmacodynamic data regarding meclizine.

12.3 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 T


max value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form.


DistributionDrug distribution characteristics for meclizine in humans are unknown. EliminationMeclizine has a plasma elimination half-life of about 5 to 6 hours in humans.Metabolism 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.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

CarcinogenesisAnimal studies to assess the carcinogenic potential of meclizine have not been conducted.Mutagenesis Genetic toxicology studies of meclizine have not been conducted.Impairment of Fertility Animal studies to assess the effects of meclizine on fertility and early embryonic development have not been conducted.

16.1 How Supplied

Meclizine Hydrochloride Tablets USP,


12.5 mg are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side.


They are available as follows:Bottles of 30:              NDC 65162-441-03Bottles of 100:            NDC 65162-441-10Bottles of 500:            NDC 65162-441-50Bottles of 1000:          NDC 65162-441-11Blister packs:              NDC 65162-441-60(Packages of 100 unit doses, 10 cards of 10 tablets each)Meclizine Hydrochloride Tablets USP,


25 mg are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side.


They are available as follows:Bottles of 30:              NDC 65162-442-03Bottles of 100:            NDC 65162-442-10Bottles of 500:            NDC 65162-442-50Bottles of 1000:          NDC 65162-442-11Blister packs:              NDC 65162-442-60(Packages of 100 unit doses, 10 cards of 10 tablets each)Meclizine Hydrochloride Tablets USP,


50 mg are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side.


They are available as follows:Bottles of 30:              NDC 65162-444-03Bottles of 100:            NDC 65162-444-10Bottles of 500:            NDC 65162-444-50Bottles of 1000:          NDC 65162-444-11Blister packs:              NDC 65162-444-60(Packages of 100 unit doses, 10 cards of 10 tablets each)

16.2 Storage And Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Keep this and all medication out of the reach of children.

17 Patient Counseling Information

Administration InstructionsAdvise patients that the tablets must be swallowed whole


[see


Dosage and Administration (2.1)].


Adverse ReactionsAdvise patients that meclizine hydrochloride may cause anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision


[see


Warnings and Precautions (5.1),


Adverse Reactions (6)].


Inform patients that meclizine hydrochloride may impair their ability to engage in potentially dangerous activities, such as operating machinery or vehicles. Concomitant Drug InteractionsAdvise patients regarding medications that should not be taken in combination with meclizine hydrochloride or that may necessitate increased monitoring


[see


Drug Interactions (7.1,


7.2)].


Inform patients that alcohol may increase adverse reactions.


Concurrent Medical Conditions Advise patients to notify their healthcare provider about all of their medical conditions, including if they are pregnant or plan to become pregnant or if they are breastfeeding


[see


Warnings and Precautions (5.2),


Use in Specific Populations (8.1,


8.2)]


.


Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. 07-2019-04

* Please review the disclaimer below.