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Meclizine Hydrochloride 25 mg Tablet, 100-count — NDC 16571-0661-01 package photo

Meclizine Hydrochloride 25 mg Tablet, 100-count

by Rising Pharma Holdings, Inc. · 100 TABLET in 1 BOTTLE (16571-661-01)
NDC 16571-0661-01
🏷️ FDA NDC (as labeled) 16571-661-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0777 NADAC Per package$7.77 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2343/unit · Part D plans $0.1825/unit — full pricing hub ↓
Also comes in: 1000 tablets 16571-0661-10
Rx only Brand 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

⚠️
Other active recalls for Meclizine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 16, 2026 — Failed tablet specifications. (Amerisource Health Services LLC) · FDA recall D-0418-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 16571-661-01
Product NDC 16571-661
11-digit billing NDC 16571066101
NCPDP billing unit EA — each (per item)
RxCUI 995624, 995632, 995666, 995686
UNII HDP7W44CIO
Application # NDA010721
SPL Set ID c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd
Established class (EPC) Antiemetic
Physiologic effect Emesis Suppression
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-15
Route ORAL
Dosage form TABLET
Substance MECLIZINE HYDROCHLORIDE
GPI-14 50200050000310
GPI class Meclizine HCl
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
Why two NDCs? The FDA registers this code as 16571-661-01 — 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 → 16571-0661-01. 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

LabelerRising Pharma Holdings, Inc.
Application holderCASPER PHARMA LLC
FDA applicationNDA010721 (NDA AUTHORIZED GENERIC)
Labeler code16571
First marketedJan 2020
Product typeHuman Prescription Drug
Portfolio525 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 →

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 Blue / Yellow / Pink
ShapeRound
ImprintM;25
Size8 mm
ScoringScored — splits in 2
FlavorRaspberry
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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 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 $0.078 $7.77 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2343 $23.43 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1825 $18.25 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.121 $0.078
▼ Down 32% over the last 24 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 $0.078 AA Availability likely —
Meclizine Hydrochloride 25 mgthis 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 +3%
Meclizine Hydrochloride 25 mg 24689-0139-01 APNAR 100 tablets $0.134 — Availability likely +73%
Meclizine Hydrochloride 25 mg 24689-0146-01 APNAR 100 tablets $0.134 — Availability likely +73%
Motion Sickness Relief 25 mg 46122-0535-51 Amerisource 8 tablets $0.134 — Availability likely +73%
Motion Sickness Relief 25 mg 70000-0097-01 Cardinal 32 tablets $0.134 — Availability likely +73%
Motion Sickness 25 mg 70677-1088-01 Strategic 8 tablets $0.134 — Availability likely +73%
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 —
ZenTrip Motion Sickness 25 mg 49873-0805-01 Sato 12 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 67046-0869-03 Coupler 30 tablets — — FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 16571-0661-01, 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
76.4K
Units reimbursed last 4 qtrs
3.4M
Gross reimbursed last 4 qtrs
$787.7K
Avg / prescription
$10.31
Avg / unit
$0.2343
Latest quarter Q4 2025
18.6KRx
Medicaid pays / ea
$0.2343
gross reimbursed
vs
NADAC / ea
$0.0777
acquisition cost
=
Spread
+$0.1566
+202% 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 ⓘ
37% FFS 63% MCO
Fee-for-service · 28,650 Rx Managed care · 47,757 Rx
State Medicaid map
Alaska: 8,688 units · 1,185 per 100k residents AK Maine: 19,262 units · 1,381 per 100k residents ME Washington: 62,921 units · 805 per 100k residents WA Idaho: 23,471 units · 1,195 per 100k residents ID Montana: 5,218 units · 461 per 100k residents MT North Dakota: 9,203 units · 1,175 per 100k residents ND Minnesota: 80,854 units · 1,409 per 100k residents MN Wisconsin: 50,298 units · 851 per 100k residents WI Michigan: 221,124 units · 2,203 per 100k residents MI New York: 210,077 units · 1,073 per 100k residents NY Vermont: 3,647 units · 564 per 100k residents VT New Hampshire: 15,143 units · 1,080 per 100k residents NH Oregon: 32,671 units · 772 per 100k residents OR Nevada: 40,011 units · 1,253 per 100k residents NV Wyoming: 2,823 units · 483 per 100k residents WY South Dakota: 8,835 units · 961 per 100k residents SD Iowa: 24,444 units · 762 per 100k residents IA Illinois: 53,735 units · 428 per 100k residents IL Indiana: 41,635 units · 607 per 100k residents IN Ohio: 114,265 units · 970 per 100k residents OH Pennsylvania: 82,629 units · 638 per 100k residents PA New Jersey: 70,434 units · 758 per 100k residents NJ Massachusetts: 282,435 units · 4,034 per 100k residents MA California: 334,515 units · 859 per 100k residents CA Utah: 17,985 units · 526 per 100k residents UT Colorado: 60,525 units · 1,030 per 100k residents CO Nebraska: 7,394 units · 374 per 100k residents NE Missouri: 40,563 units · 655 per 100k residents MO Kentucky: 148,808 units · 3,288 per 100k residents KY West Virginia: 53,829 units · 3,041 per 100k residents WV Virginia: 282,123 units · 3,237 per 100k residents VA Maryland: 64,656 units · 1,046 per 100k residents MD Connecticut: 153,757 units · 4,251 per 100k residents CT Rhode Island: 71,835 units · 6,560 per 100k residents RI Arizona: 76,290 units · 1,027 per 100k residents AZ New Mexico: 7,666 units · 363 per 100k residents NM Kansas: 17,637 units · 600 per 100k residents KS Arkansas: 16,531 units · 539 per 100k residents AR Tennessee: 45,418 units · 637 per 100k residents TN North Carolina: 192,583 units · 1,777 per 100k residents NC South Carolina: 18,967 units · 353 per 100k residents SC Delaware: 787 units · 76.3 per 100k residents DE Oklahoma: 9,798 units · 242 per 100k residents OK Louisiana: 56,702 units · 1,240 per 100k residents LA Mississippi: 7,641 units · 260 per 100k residents MS Alabama: 16,798 units · 329 per 100k residents AL Georgia: 91,482 units · 829 per 100k residents GA D.C.: 21,111 units · 3,109 per 100k residents DC Hawaii: 6,691 units · 466 per 100k residents HI Texas: 45,979 units · 151 per 100k residents TX Florida: 29,525 units · 131 per 100k residents FL
Units reimbursed · per 100k residents
76.36,560
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 Rhode Island 6,560 /100k
2 Connecticut 4,251 /100k
3 Massachusetts 4,034 /100k
4 Kentucky 3,288 /100k
5 Virginia 3,237 /100k
6 D.C. 3,109 /100k
7 West Virginia 3,041 /100k
8 Michigan 2,203 /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.
1000 tablets16571-0661-10 89,962 Rx · $1,113,755
100 tablets this page16571-0661-01 76,407 Rx · $787,687
Drug total (last 4 qtrs): 166,369 Rx · 7,675,831 units · $1,901,441 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 — the ingredient across all brands.

Top reported reactions

Dizziness1,949
Nausea1,743
Fatigue1,649
Headache1,272
Diarrhoea1,239
Fall1,194
Pain1,171

Age at onset

Neonate22
Infant8
Child2
Adolescent16
Adult1,416
Elderly1,654

Reporter sex

19,471 reports
Male · 26%
Female · 74%
Unknown · 0%

Serious outcomes

Hospitalization5,856
Death1,695
Disabling482
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,720 0
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
16571-0661-01 You're viewing this 100 TABLET in 1 BOTTLE (16571-661-01) $0.0777 / ea $7.77 2020-01-15 Active
16571-0661-10 1000 TABLET in 1 BOTTLE (16571-661-10) $0.0777 / ea $77.70 2020-01-15 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 ($0.0777 NADAC).

This pack accounts for about 46% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 16571-0661-01?
NDC 16571-0661-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 16571-0661-01 and NDC 16571-0661-10?
Both are Meclizine Hydrochloride 25 mg Tablet — the drug itself is identical. NDC 16571-0661-01 is the 100-count package, while NDC 16571-0661-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Meclizine Hydrochloride 25 mg Tablet?
Bill NDC 16571-0661-01 — the 11-digit billing format is 16571066101. 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 40 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.

⏱️ Dosage and Administration 93 words ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ). Tablets: Swallow whole ( 2.2 ). Chewable Tablets: Must be chewed or crushed before swallowing; do not 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. Chewable Tablets Meclizine hydrochloride chewable tablets must be chewed or crushed completely before swallowing. Do not swallow chewable tablets whole.

💊 Dosage Forms and Strengths 121 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets 12.5 mg: oval-shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “34” and one white to off white layer debossed with “L”. 25 mg: oval-shaped, biconvex, two-layered tablet, one yellow to pale yellow layer debossed with “49” and one white to off white layer debossed with “L”. 50 mg: oval-shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “50” and one yellow to pale yellow layer and debossed with “L”.

Chewable Tablets 25 mg: pink colored round tablets debossed with “M 25” on one side and break line on other side. Tablets: 12.5 mg, 25 mg, and 50 mg ( 3 ). Chewable Tablets: 25 mg ( 3 ).

⛔ Contraindications 44 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.

⚠️ Warnings and Cautions 118 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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 110 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 2-4% and 15-20%, 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/m2) 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 183 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 2-4% and 15-20%, 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/m2) 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 188 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Tablets Meclizine hydrochloride 12.5 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “34” and one white to off white layer debossed with “L”. Bottles of 100 NDC 16571-660-01 Bottles of 500 NDC 16571-660-50 Meclizine hydrochloride 25 mg tablets are oval shaped, biconvex, two-layered tablet, one yellow to pale yellow layer debossed with “49” and one white to off white layer debossed with “L”. Bottles of 100 NDC 16571-661-01 Bottles of 1000 NDC 16571-661-10 Meclizine hydrochloride 50 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “50” and one yellow to pale yellow layer and debossed with “L”.

Bottles of 100 NDC 16571-662-01 Chewable Tablets Meclizine hydrochloride 25 mg chewable tablets are pink colored round tablets debossed with “M 25” on one side and break line on other side. Bottles of 100 NDC 16571-663-01

16.2Storage and Handling Store at 20 o C to 25 o C (68 o F to 77 o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

📋 Description 202 words ▾

11 DESCRIPTION Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula: Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Tablets Inactive ingredients for the tablets are: corn starch; dibasic calcium phosphate; magnesium stearate; polyethylene glycol; sucrose.

The 12.5 mg tablets also contain: FD&C Blue # 1. The 25 mg tablets also contain: FD&C Yellow # 6 and D&C Yellow # 10. The 50 mg tablets also contain: FD&C Blue # 1, FD&C Yellow # 6 and D&C Yellow # 10.

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.

Chewable Tablets Inactive ingredients for the chewable tablets are: corn starch, colloidal silicon dioxide, FD&C Red # 40, lactose monohydrate, magnesium stearate, raspberry flavor, saccharin sodium, and talc. Each meclizine hydrochloride 25 mg chewable tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. struct-1.jpg

💬 Information for Patients 184 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 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) ] .

Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 PIA66201-01 Revised: 05/2025

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 16571-0660-01 · Rising 16571-0662-01 · Rising →
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.