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MECLIZINE HYDROCHLORIDE 25 mg Tablet, 100-count — NDC 59651-0808-01 package photo

MECLIZINE HYDROCHLORIDE 25 mg Tablet, 100-count

by Aurobindo Pharma Limited · 100 TABLET in 1 BOTTLE (59651-808-01)
NDC 59651-0808-01
🏷️ FDA NDC (as labeled) 59651-808-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0757 NADAC Per package$7.57 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2193/unit · Part D plans $0.1168/unit — full pricing hub ↓
Also comes in: 1000 tablets 59651-0808-99
Rx only Generic On market Non-controlled
🗂️ 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

🆔 Identity & classification

FDA NDC (as labeled) 59651-808-01
Product NDC 59651-808
11-digit billing NDC 59651080801
NCPDP billing unit EA — each (per item)
RxCUI 995624, 995666, 995686
UNII HDP7W44CIO
Application # ANDA202640
SPL Set ID beb3c7f2-c0f4-41d9-a903-63a6847e0997
Established class (EPC) Antiemetic
Physiologic effect Emesis Suppression
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-14
Route ORAL
Dosage form TABLET
Substance MECLIZINE HYDROCHLORIDE
GPI-14 50200050000310
GCN Seq No 004732
GCN 18302
HICL code 001975
Ingredient (HICL) Meclizine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 04:04.16.00
AHFS class Piperazine Derivatives
FDB label name MECLIZINE 25 MG TABLET
FDB brand name Meclizine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 59651-808-01 — a 5-3-2 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 product segment → 59651-0808-01. 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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA USA INC
FDA applicationANDA202640 (ANDA)
Labeler code59651
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio1,456 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

Label name MECLIZINE 25 MG TABLET Ingredient Meclizine Hcl
📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗
📗 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 →
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 White
ShapeRound
ImprintC;50
Size1 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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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.

5 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 eaPer package
Retail pharmacies payNADAC · weekly $0.076 $7.57 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2193 $21.93 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1168 $11.68 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.084 $0.076
▼ Down 10% over the last 10 months.
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 $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 16571-0661-01 Rising 100 tablets $0.076 — Availability likely —
Meclizine Hydrochloride 25 mg 50268-0523-15 AvPAK 50 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 53746-0442-01 Amneal 100 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mgthis 59651-0808-01 Aurobindo 100 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 60687-0730-01 American 100 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 62135-0953-90 Chartwell 90 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 70710-1162-00 Zydus 1000 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 42806-0014-01 Epic 100 tablets $0.078 AA Availability likely +3%
Meclizine Hydrochloride 25 mg 59746-0121-06 Jubilant 100 tablets $0.080 AA Availability likely +6%
Meclizine Hydrochloride 25 mg 24689-0139-01 APNAR 100 tablets $0.128 — Availability likely +69%
Meclizine Hydrochloride 25 mg 24689-0146-01 APNAR 100 tablets $0.128 — Availability likely +69%
Motion Sickness Relief 25 mg 46122-0535-51 Amerisource 8 tablets $0.128 — Availability likely +69%
Motion Sickness Relief 25 mg 70000-0097-01 Cardinal 32 tablets $0.128 — Availability likely +69%
Motion Sickness 25 mg 70677-1088-01 Strategic 8 tablets $0.128 — Availability likely +69%
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 mg 71335-0503-00 Bryant 14 tablets — AA FDA listed —
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 —
Meclizine Hydrochloride 25 mg 71335-3157-00 Bryant 14 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 68788-4170-01 Preferred 10 tablets — AA 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

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 59651-0808-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
66.9K
Units reimbursed last 4 qtrs
2.9M
Gross reimbursed last 4 qtrs
$630.6K
Avg / prescription
$9.43
Avg / unit
$0.2193
Latest quarter Q4 2025
17.6KRx
Medicaid pays / ea
$0.2193
gross reimbursed
vs
NADAC / ea
$0.0757
acquisition cost
=
Spread
+$0.1436
+190% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
38% FFS 62% MCO
Fee-for-service · 25,677 Rx Managed care · 41,178 Rx
State Medicaid map
Alaska: 5,125 units · 699 per 100k residents AK Maine: 34,022 units · 2,439 per 100k residents ME Washington: 52,410 units · 671 per 100k residents WA Idaho: 13,611 units · 693 per 100k residents ID Montana: 5,422 units · 479 per 100k residents MT North Dakota: no data reported ND Minnesota: 51,260 units · 893 per 100k residents MN Wisconsin: 58,156 units · 984 per 100k residents WI Michigan: 70,859 units · 706 per 100k residents MI New York: 96,058 units · 491 per 100k residents NY Vermont: 7,317 units · 1,131 per 100k residents VT New Hampshire: 10,597 units · 756 per 100k residents NH Oregon: 44,726 units · 1,057 per 100k residents OR Nevada: 60,412 units · 1,891 per 100k residents NV Wyoming: 2,190 units · 375 per 100k residents WY South Dakota: 3,773 units · 411 per 100k residents SD Iowa: 21,802 units · 680 per 100k residents IA Illinois: 120,347 units · 959 per 100k residents IL Indiana: 87,294 units · 1,272 per 100k residents IN Ohio: 121,717 units · 1,033 per 100k residents OH Pennsylvania: 97,636 units · 753 per 100k residents PA New Jersey: 34,609 units · 373 per 100k residents NJ Massachusetts: 22,898 units · 327 per 100k residents MA California: 445,409 units · 1,143 per 100k residents CA Utah: 16,158 units · 473 per 100k residents UT Colorado: 51,563 units · 877 per 100k residents CO Nebraska: 17,827 units · 901 per 100k residents NE Missouri: 99,388 units · 1,604 per 100k residents MO Kentucky: 105,721 units · 2,336 per 100k residents KY West Virginia: 60,066 units · 3,394 per 100k residents WV Virginia: 131,730 units · 1,511 per 100k residents VA Maryland: 28,984 units · 469 per 100k residents MD Connecticut: 19,327 units · 534 per 100k residents CT Rhode Island: 7,242 units · 661 per 100k residents RI Arizona: 112,856 units · 1,519 per 100k residents AZ New Mexico: 33,141 units · 1,568 per 100k residents NM Kansas: 10,858 units · 369 per 100k residents KS Arkansas: 22,805 units · 744 per 100k residents AR Tennessee: 59,942 units · 841 per 100k residents TN North Carolina: 113,985 units · 1,052 per 100k residents NC South Carolina: 8,168 units · 152 per 100k residents SC Delaware: 2,682 units · 260 per 100k residents DE Oklahoma: 66,005 units · 1,629 per 100k residents OK Louisiana: 140,176 units · 3,065 per 100k residents LA Mississippi: 21,517 units · 732 per 100k residents MS Alabama: 35,111 units · 687 per 100k residents AL Georgia: 62,128 units · 563 per 100k residents GA D.C.: 1,638 units · 241 per 100k residents DC Hawaii: 4,547 units · 317 per 100k residents HI Texas: 64,773 units · 212 per 100k residents TX Florida: 109,751 units · 485 per 100k residents FL
Units reimbursed · per 100k residents
1523,394
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 3,394 /100k
2 Louisiana 3,065 /100k
3 Maine 2,439 /100k
4 Kentucky 2,336 /100k
5 Nevada 1,891 /100k
6 Oklahoma 1,629 /100k
7 Missouri 1,604 /100k
8 New Mexico 1,568 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page59651-0808-01 66,855 Rx · $630,632
1000 tablets59651-0808-99 59,010 Rx · $657,365
Drug total (last 4 qtrs): 125,865 Rx · 5,460,012 units · $1,287,997 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Per unit Per pack Marketing startStatus
59651-0808-01 You're viewing this 100 TABLET in 1 BOTTLE (59651-808-01) $0.0757 / ea $7.57 2023-09-14 Active
59651-0808-99 1000 TABLET in 1 BOTTLE (59651-808-99) $0.0757 / ea $75.68 2023-09-14 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0757 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 53% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 59651-0808-01?
NDC 59651-0808-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 59651-0808-01 and NDC 59651-0808-99?
Both are MECLIZINE HYDROCHLORIDE 25 mg Tablet — the drug itself is identical. NDC 59651-0808-01 is the 100-count package, while NDC 59651-0808-99 is the 1000 tablets package.
What NDC number is used to bill for this package of MECLIZINE HYDROCHLORIDE 25 mg Tablet?
Bill NDC 59651-0808-01 — the 11-digit billing format is 59651080801. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 45 words ▾

1 INDICATIONS AND USAGE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are 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 146 words ▾

3 DOSAGE FORMS AND STRENGTHS Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg, 25 mg or 50 mg of meclizine dihydrochloride equivalent to 10.53 mg, 21.07 mg or 42.14 mg of meclizine free base, respectively. The 12.5 mg tablets are a white to off-white 7.14 mm round, biconvex, beveled edge tablets debossed with 12 on one side of tablet and C on the other side of tablet. The 25 mg tablets are a white to off-white 8.73 mm round, biconvex, beveled edge tablets debossed with 25 on one side of tablet and C on the other side of tablet.

The 50 mg tablets are a white to off-white 10.32 mm round, biconvex, beveled edge tablets debossed with C above the score on one side of tablet and 50 on the other side of tablet. Tablets: 12.5 mg, 25 mg and 50 mg ( 3 ).

⛔ Contraindications 48 words ▾

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) ]. Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients ( 4 ).

⚠️ Warnings and Cautions 121 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 tablets, 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 tablets [see Drug Interactions (7.1) ] .

5.2Concurrent Medical Conditions Because of its potential anticholinergic action, meclizine hydrochloride tablets 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 114 words ▾

7 DRUG INTERACTIONS Coadministration of meclizine hydrochloride tablets 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 tablets and CYP2D6 inhibitors ( 7.2 ).

7.1CNS Depressants There may be increased CNS depression when meclizine hydrochloride tablets are 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 tablets 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 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.

8.2Lactation 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 tablets and any potential adverse effects on the breastfed infant from meclizine hydrochloride tablets 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 undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine. Treatment with meclizine hydrochloride tablets 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 tablets 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 tablets are administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

🤰 Pregnancy 191 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 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.

🧒 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 141 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 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.

🧬 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 215 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg, 25 mg or 50 mg of meclizine dihydrochloride equivalent to 10.53 mg, 21.07 mg or 42.14 mg of meclizine free base, respectively. The 12.5 mg tablets are a white to off-white 7.14 mm round, biconvex, beveled edge tablets debossed with 12 on one side of tablet and C on the other side of tablet. They are available as follows: Bottles of 100 NDC 59651-807-01 Bottles of 1,000 NDC 59651-807-99 The 25 mg tablets are a white to off-white 8.73 mm round, biconvex, beveled edge tablets debossed with 25 on one side of tablet and C on the other side of tablet.

They are available as follows: Bottles of 100 NDC 59651-808-01 Bottles of 1,000 NDC 59651-808-99 The 50 mg tablets are a white to off-white 10.32 mm round, biconvex, beveled edge tablets debossed with C above the score on one side of tablet and 50 on the other side of tablet. They are available as follows: Bottles of 90 NDC 59651-809-90 Bottles of 500 NDC 59651-809-05

16.2Storage and Handling 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.

📋 Description 116 words ▾

11 DESCRIPTION Meclizine hydrochloride, USP a histamine (H1) receptor antagonist, is a white to slight 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: Inactive ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.

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.

Chemical Structure

💬 Information for Patients 199 words ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions: Advise patients that the tablets must be swallowed whole, but chewable tablets must be chewed or crushed completely before swallowing [see Dosage and Administration (2.1) ] . Adverse Reactions: Advise patients that meclizine hydrochloride tablets 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 tablets 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 tablets 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: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 08/2023

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59651-0807-01 · Aurobindo 59651-0809-05 · Aurobindo →
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.