Meclizine Hydrochloride

Manufacturer: Mylan Pharmaceuticals Inc.
Effective date: 2018-04-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-02 00:33:42

Label at a glance#

ProductMeclizine Hydrochloride

Active ingredientMECLIZINE HYDROCHLORIDE

Label structure11 sections

Indications and uses

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

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.

Contacts and useful links#

PhoneLabel contact1-877-446-3679

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Chemically, meclizine hydrochloride, USP is 1-(p-Chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. The molecular weight is 481.88 g/mole.

Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg.

Inert ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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

PHARMACOKINETICS SECTION

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

Absorption

SPL UNCLASSIFIED SECTION

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.

Distribution

SPL UNCLASSIFIED SECTION

Drug distribution characteristics for meclizine in humans are unknown.

Metabolism

SPL UNCLASSIFIED SECTION

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.

Elimination

SPL UNCLASSIFIED SECTION

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

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

WARNINGS

WARNINGS SECTION

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

PRECAUTIONS SECTION

Pediatric Use

PEDIATRIC USE SECTION

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 Use

PREGNANCY SECTION

Pregnancy Category B

SPL UNCLASSIFIED SECTION

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

NURSING MOTHERS SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

DRUG INTERACTIONS SECTION

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

ADVERSE REACTIONS SECTION

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

To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg or 25 mg of meclizine hydrochloride, USP.

The 12.5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 12 on the other side. They are available as follows:

NDC 0378-5485-77
bottles of 90 tablets

NDC 0378-5485-10
bottles of 1000 tablets

The 25 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 25 on the other side. They are available as follows:

NDC 0378-5486-77
bottles of 90 tablets

NDC 0378-5486-10
bottles of 1000 tablets

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

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 4/2018
MECL:R4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 12.5 mg

NDC 0378-5485-77

Meclizine
Hydrochloride
Tablets, USP
12.5 mg

Rx only 90 Tablets

Each tablet contains:
Meclizine
hydrochloride, USP 12.5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

MOTION SICKNESS: 25 mg to 50 mg
daily.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM5485MM1

Meclizine Hydrochloride Tablets, USP 12.5 mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 25 mg

NDC 0378-5486-77

Meclizine
Hydrochloride
Tablets, USP
25 mg

Rx only 90 Tablets

Each tablet contains:
Meclizine
hydrochloride, USP 25 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

MOTION SICKNESS: 25 mg to 50 mg
daily.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM5486MM1

Meclizine Hydrochloride Tablets, USP 25 mg Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5485-10	EA - Each	0378-5485	f6697584-fd89-405f-a529-cb0091a6f238	1	2013-02-13
0378-5485-77	EA - Each	0378-5485	392de753-66e3-4801-b3d9-40e9bf2f52d2	1	2013-02-13
0378-5486-10	EA - Each	0378-5486	d8175ebd-ee68-4f54-a916-f32260a4615e	1	2013-02-13
0378-5486-77	EA - Each	0378-5486	21806760-f7d0-4722-951b-18afaadb6285	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	3
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Meclizine Hydrochloride
Meclizine
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSPOVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0378-5485	0378-5485-77, 0378-5485-10
0378-5486	0378-5486-77, 0378-5486-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSPOVIDONE, UNSPECIFIED	2S7830E561	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSPOVIDONE, UNSPECIFIED	2S7830E561	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 137 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		316 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, CHEWABLE / ORAL		2850 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL		2906 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	CAPSULE, EXTENDED RELEASE / ORAL		869 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	GRANULE, FOR SUSPENSION / ORAL		3025 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, DELAYED RELEASE / ORAL		1083 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	25 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	25 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	POWDER, FOR SUSPENSION / ORAL		469 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TROCHE / ORAL		300 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202640-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17
A202640-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17
A202640-003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202640-001	AA
A202640-002	AA
A202640-003	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202640-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202640-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202640-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202640-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202640-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202640-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202640-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202640-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202640-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-001	AA	1	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bf8f38e7-8b67-4646-9a20-5cb24b2bb736			595ba2cb-b31f-4cff-b86e-40e72109a582	2018-04-25	Warnings, Adverse reactions	Exact identifier spl id: bf8f38e7-8b67-4646-9a20-5cb24b2bb736 spl set id: 595ba2cb-b31f-4cff-b86e-40e72109a582

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.