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MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride 25 mg Tablet, 20-count — NDC 71335-0503-04 package photo

MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride 25 mg Tablet, 20-count

by Bryant Ranch Prepack · 20 TABLET in 1 BOTTLE (71335-0503-4)
NDC 71335-0503-04
🏷️ FDA NDC (as labeled) 71335-0503-4 billing pads the package segment with a zero
This package
Contains20-count Pack sizes10 compare ↓
Also priced by: Part D plans $0.1168/unit — full pricing hub ↓
Also comes in: 10 tablets 71335-0503-08 14 tablets 71335-0503-00 25 tablets 71335-0503-03 30 tablets 71335-0503-02 40 tablets 71335-0503-05 60 tablets 71335-0503-06 90 tablets 71335-0503-01 100 tablets 71335-0503-09 120 tablets 71335-0503-07
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Feb 2022. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-0503-4
Product NDC 71335-0503
11-digit billing NDC 71335050304
RxCUI 995666
UNII HDP7W44CIO
Application # ANDA040659
SPL Set ID f43bf077-3f29-48ec-8ca8-eb294dbf2001
Established class (EPC) Antiemetic
Physiologic effect Emesis Suppression
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Feb 2022)
Marketing start 2010-06-04
Marketing end 2026-10-31
Route ORAL
Dosage form TABLET
Substance MECLIZINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 71335-0503-4 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71335-0503-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Antiemetic class.

Pharmacologic class Antiemetic
Drug family (ATC) Piperazine derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderJUBILANT CADISTA PHARMACEUTICALS INC
FDA applicationANDA040659 (ANDA)
Labeler code71335
First marketedJun 2010
Product typeHuman Prescription Drug
Portfolio4,433 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Meclizine is mainly used to prevent and treat the nausea, vomiting, and dizziness that comes with motion sickness — whether you're on a boat, in a car, or on a plane. It's also use...
  • For the best chance of preventing motion sickness, take meclizine about one hour before you start traveling. After that first dose, you can take it once every 24 hours as needed fo...
  • Yes, drowsiness is the most common side effect — it's actually worth planning around. Avoid driving or operating heavy machinery until you know how it affects you. And definitely s...
  • This one requires a conversation with your doctor. Human studies haven't clearly linked meclizine to birth defects, but animal studies did show fetal harm at doses similar to what...
📖 Read our full Meclizine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow
ShapeOval
ImprintTL121
Size13 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1168 $2.34 / 20 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Meclizine Hydrochloride 25 mg 00904-7376-61 Major 100 tablets $0.078 AA Availability likely —
Meclizine Hydrochloride 25 mg 16571-0661-01 Rising 100 tablets $0.078 — Availability likely —
Meclizine Hydrochloride 25 mg 42806-0014-01 Epic 100 tablets $0.078 AA Availability likely —
Meclizine Hydrochloride 25 mg 50268-0523-15 AvPAK 50 tablets $0.078 AA Availability likely —
Meclizine Hydrochloride 25 mg 53746-0442-01 Amneal 100 tablets $0.078 AA Availability likely —
Meclizine Hydrochloride 25 mg 59651-0808-01 Aurobindo 100 tablets $0.078 AA Availability likely —
Meclizine Hydrochloride 25 mg 60687-0730-01 American 100 tablets $0.078 AA Availability likely —
Meclizine Hydrochloride 25 mg 62135-0953-90 Chartwell 90 tablets $0.078 AA Availability likely —
Meclizine Hydrochloride 25 mg 70710-1162-00 Zydus 1000 tablets $0.078 AA Availability likely —
Meclizine Hydrochloride 25 mg 59746-0121-06 Jubilant 100 tablets $0.080 AA Availability likely —
Meclizine Hydrochloride 25 mg 24689-0139-01 APNAR 100 tablets $0.134 — Availability likely —
Meclizine Hydrochloride 25 mg 24689-0146-01 APNAR 100 tablets $0.134 — Availability likely —
Motion Sickness Relief 25 mg 46122-0535-51 Amerisource 8 tablets $0.134 — Availability likely —
Motion Sickness Relief 25 mg 70000-0097-01 Cardinal 32 tablets $0.134 — Availability likely —
Motion Sickness 25 mg 70677-1088-01 Strategic 8 tablets $0.134 — Availability likely —
Motion Sickness Relief 25 mg 00363-4030-21 Walgreen 16 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 00615-8515-39 NCS 30 tablets — AA FDA listed —
PhysiciansCare Motion Sickness 25 mg 00924-1008-00 Acme 2 tablets — — FDA listed —
Motion Sickness Relief 25 mg 11673-0356-08 TARGET 8 tablets — — FDA listed —
Less Drowsy Motion Sickness Relief 25 mg 11822-0775-09 Rite 8 tablets — — FDA listed —
Motion Sickness Relief Less Drowsy 25 mg 21130-0778-02 Better 12 tablets — — FDA listed —
Motion Sickness Relief 25 mg 30142-0943-19 Kroger 8 tablets — — FDA listed —
Motion Sickness Relief 25 mg 36800-0943-19 Topco 8 tablets — — FDA listed —
Motion Sickness 25 mg 37808-0903-12 H 100 tablets — — FDA listed —
Motion Sickness Relief 25 mg 41163-0304-02 United 12 tablets — — FDA listed —
Motion Sickness Relief 25 mg 41250-0930-19 Meijer 8 tablets — — FDA listed —
Meclizine Hydrocloride 25 mg 42708-0102-30 QPharma 30 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 42708-0127-30 QPharma 30 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 42708-0189-30 QPharma 30 tablets — AA FDA listed —
Medique Medi-Meclizine 25 mg 47682-0481-15 Unifirst 1000 tablets — — FDA listed —
Less Drowsy Motion Sickness Relief 25 mg 49035-0403-19 Wal-Mart 8 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 50090-5727-02 A-S 12 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 50090-5728-00 A-S 20 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 50090-7416-02 A-S 12 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 50090-7417-00 A-S 20 tablets — AA FDA listed —
Dramamine Less Drowsy Meclizine Hydrochloride 25 mg 50269-0526-00 JC 40 tablets — — FDA listed —
Motion Sickness Relief 25 mg 50844-0403-19 L.N.K. 8 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 51655-0107-20 Northwind 20 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 51655-0175-52 Northwind 30 tablets — AA FDA listed —
Motion Sickness 25 mg 55301-0403-21 ARMY 16 tablets — — FDA listed —
Motion Sickness Relief 25 mg 55319-0903-19 Family 8 tablets — — FDA listed —
Motion Sickness Relief 25 mg 55910-0943-19 DOLGENCORP, 8 tablets — — FDA listed —
Less Drowsy Formula Motion Sickness Relief 25 mg 57243-0403-02 Salado 12 tablets — — FDA listed —
Travel-Ease 25 mg 57896-0378-01 Geri-Care 100 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 60760-0661-30 St. 30 tablets — — FDA listed —
Dramamine Less Drowsy 25 mg 63029-0903-01 Medtech 8 tablets — — FDA listed —
Dramamine - N 25 mg 63029-0905-10 Medtech 10 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 63187-0258-10 Proficient 10 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 63187-0996-10 Proficient 10 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 65162-0442-03 Amneal 30 tablets — AA FDA listed —
Dramamine Less Drowsy, Lil Drug Store 25 mg 66715-9734-01 Lil' 2 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 67296-2138-02 Redpharm 21 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 67296-2205-02 Redpharm 21 tablets — AA FDA listed —
Dramamine Less Drowsy 25 mg 67751-0242-02 Navajo 2 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 68071-2380-02 NuCare 20 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 68071-2416-06 NuCare 6 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 68071-3017-01 NuCare 12 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 68071-3748-04 NuCare 4 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 68071-3791-02 NuCare 20 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 69842-0857-05 CVS 16 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 70518-1308-00 REMEDYREPACK 90 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 70518-3815-00 REMEDYREPACK 21 tablets — — Discontinued —
Meclizine Hydrochloride 25 mg 70771-1540-00 Zydus 1000 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 71205-0786-10 Proficient 10 tablets — — FDA listed —
Meclizine Hydrochloride 25 mgthis 71335-0503-04 Bryant 20 tablets — AA Discontinued —
Meclizine Hydrochloride 25 mg 71335-1825-00 Bryant 14 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 72189-0237-30 Direct_Rx 30 tablets — — Discontinued —
Meclizine Hydrochloride 25 mg 76420-0130-10 Asclemed 10 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 76420-0798-01 Asclemed 100 tablets — — FDA listed —
Nausea Relief 25 mg 79903-0177-10 WALMART 10 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 80425-0494-01 Advanced 30 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 82868-0058-20 Northwind 20 tablets — AA FDA listed —
Motion Sickness Relief 25 mg 83059-0007-01 Shield 15 tablets — — FDA listed —
Pepto Nausea Motion Sickness 25 mg 84126-0340-01 THE 10 tablets — — FDA listed —
Medique Medi-Meclizine 25 mg 85766-0175-00 Sportpharm 1000 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2010
On the market since
Jun 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Meclizine Hydrochloride (this brand).

Top reported reactions

Dizziness1,631
Nausea1,420
Fatigue1,369
Headache1,059
Diarrhoea1,047
Pain1,008
Fall997

Age at onset

Neonate22
Child1
Adolescent16
Adult1,197
Elderly1,492

Reporter sex

16,229 reports
Male · 26%
Female · 74%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,154 565
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71335-0503-00 14 TABLET in 1 BOTTLE (71335-0503-0) 2022-02-23 Active
71335-0503-01 90 TABLET in 1 BOTTLE (71335-0503-1) 2022-02-23 Discontinued by firm
71335-0503-02 30 TABLET in 1 BOTTLE (71335-0503-2) 2022-02-23 Discontinued by firm
71335-0503-03 25 TABLET in 1 BOTTLE (71335-0503-3) 2022-02-23 Discontinued by firm
71335-0503-04 You're viewing this 20 TABLET in 1 BOTTLE (71335-0503-4) 2022-02-23 Discontinued by firm
71335-0503-05 40 TABLET in 1 BOTTLE (71335-0503-5) 2022-02-23 Discontinued by firm
71335-0503-06 60 TABLET in 1 BOTTLE (71335-0503-6) 2022-02-23 Discontinued by firm
71335-0503-07 120 TABLET in 1 BOTTLE (71335-0503-7) 2022-02-23 Discontinued by firm
71335-0503-08 10 TABLET in 1 BOTTLE (71335-0503-8) 2022-02-23 Discontinued by firm
71335-0503-09 100 TABLET in 1 BOTTLE (71335-0503-9) 2022-02-23 Active

You're viewing one of 10 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-0503-04?
NDC 71335-0503-04 is a 20-count package — 20 tablet in 1 bottle.
What is the difference between NDC 71335-0503-04 and NDC 71335-0503-08?
Both are MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride 25 mg Tablet — the drug itself is identical. NDC 71335-0503-04 is the 20-count package, while NDC 71335-0503-08 is the 10 tablets package.
What NDC number is used to bill for this package of MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride 25 mg Tablet?
Bill NDC 71335-0503-04 — the 11-digit billing format is 71335050304. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71335-0503-4, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-0503-04, written without dashes as 71335050304. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71335-0503-04, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (0503) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 9 other package presentations of this same product, including 10 tablets (71335-0503-08), 14 tablets (71335-0503-00), 25 tablets (71335-0503-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 43 words ▾

1 INDICATIONS AND USAGE Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).

⏱️ Dosage and Administration 57 words ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ). Tablets: Swallow whole ( 2.2 ).

2.1Recommended Dosage The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response.

2.2Administration Instructions Tablets Meclizine hydrochloride tablets must be swallowed whole.

💊 Dosage Forms and Strengths 64 words ▾

3 DOSAGE FORMS AND STRENGTHS Meclizine hydrochloride tablets USP, 12.5 mg (Blue, oval shaped tablets, debossed with “TL 122” with score on one side and plain on the other side.) Meclizine hydrochloride tablets USP, 25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) Tablets: 12.5 mg, and 25 mg ( 3 ).

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS Meclizine hydrochloride is contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions (6) and Description (11) ]. Meclizine hydrochloride is contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients ( 4 ).

⚠️ Warnings and Cautions 117 words ▾

5 WARNINGS AND PRECAUTIONS May cause drowsiness: Use caution when driving a car or operating dangerous machinery ( 5.1 ). Potential anticholinergic action: this drug should be prescribed with care to patients with a history of asthma, glaucoma, or enlargement of the prostate gland ( 5.2 ).

5.1Drowsiness 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) ].

5.2Concurrent 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.

🤒 Adverse Reactions 113 words ▾

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. Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported ( 6 ).

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

🔄 Drug Interactions 109 words ▾

7 DRUG INTERACTIONS Coadministration of Meclizine hydrochloride with other CNS depressants, including alcohol, may result in increased CNS depression ( 7.1 ). CYP2D6 inhibitors: As meclizine is metabolized by CYP2D6, there is a potential for drug-drug interactions between Meclizine hydrochloride and CYP2D6 inhibitors ( 7.2 ).

7.1CNS 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) ].

7.2CYP2D6 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.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Data 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. Data Human 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 (25-250 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.

8.2Lactation Risk Summary There 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.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric 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.

8.6Hepatic 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.

8.7Renal 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.

8.8Genetic 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.

🤰 Pregnancy 189 words ▾

8.1Pregnancy Risk Summary Data 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. Data Human 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 (25-250 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.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 43 words ▾

8.5Geriatric 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.

🧬 Clinical Pharmacology 139 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics There are no relevant pharmacodynamic data regarding meclizine.

12.3Pharmacokinetics 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. Distribution Drug distribution characteristics for meclizine in humans are unknown.

Elimination Meclizine has a plasma elimination half-life of about 5-6 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.

🧬 Mechanism of Action 27 words ▾

12.1Mechanism 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.

📦 How Supplied / Storage and Handling 138 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Meclizine hydrochloride tablets, USP are available in the following strengths and package sizes: 25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) NDC 71335-0503-1: 90 Tablets in a BOTTLE NDC 71335-0503-2: 30 Tablets in a BOTTLE NDC 71335-0503-3: 25 Tablets in a BOTTLE NDC 71335-0503-4: 20 Tablets in a BOTTLE NDC 71335-0503-5: 40 Tablets in a BOTTLE NDC 71335-0503-6: 60 Tablets in a BOTTLE NDC 71335-0503-7: 120 Tablets in a BOTTLE NDC 71335-0503-8: 10 Tablets in a BOTTLE NDC 71335-0503-9: 100 Tablets in a BOTTLE NDC 71335-0503-0: 14 Tablets in a BOTTLE Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container (USP). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 138 words ▾

11 DESCRIPTION Meclizine hydrochloride, USP 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. Tablets 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 silicone 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 to 20%). 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.

💬 Information for Patients 171 words ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Advise patients that the tablets must be swallowed whole [see Dosage and Administration (2.1) ]. Adverse Reactions Advise 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 Interactions Advise 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) ].

Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Rev. # 07/2019

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-0501-01 · Bryant 71335-0504-01 · Bryant →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.