NDC 70518-2074 Meclizine Hydrochloride

Meclizine Hydrochloride

NDC Product Code 70518-2074

NDC Code: 70518-2074

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.
    • 70518-2074 - Meclizine Hydrochloride

NDC 70518-2074-0

Package Description: 20 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Meclizine Hydrochloride with NDC 70518-2074 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: 05-13-2019 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

Description

Meclizine hydrochloride, USP, an oral antiemetic, is a white or slightly yellowish, crystalline powder. It has the following structural formula:Chemically, meclizine hydrochloride, USP 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.

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.PharmacokineticsThe available pharmacokinetic information for meclizine following oral administration has been summarized from published literature.AbsorptionMeclizine 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.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 ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.EliminationMeclizine has a plasma elimination half-life of about 5 to 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 is 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 UseClinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies in rats have shown cleft palates at 25 to 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 InteractionsThere 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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage And Administration

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

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)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.Distributed by:


Amneal Pharmaceuticals LLC


Bridgewater, NJ 08807


Rev. 02-2019-03

* Please review the disclaimer below.

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