Meclizine HCl MECLIZINE HYDROCHLORIDE 12.5 mg Tablet, 100-count
by BluePoint Laboratories · 100 TABLET in 1 BOTTLE (68001-528-00)
NDC 68001-0528-00
🏷️ FDA NDC (as labeled)
68001-528-00
billing pads the product segment with a zero
OTC
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 →
⚠️
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)
68001-528-00
Product NDC
68001-528
11-digit billing NDC
68001052800
NCPDP billing unit
EA — each (per item)
RxCUI
995624
UNII
HDP7W44CIO
Application #
M009
SPL Set ID
d9cae5a6-8d4b-bdaf-e053-2995a90a7d44
Established class (EPC)
Antiemetic
Physiologic effect
Emesis Suppression
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2022-03-14
Route
ORAL
Dosage form
TABLET
Substance
MECLIZINE HYDROCHLORIDE
GPI-14
50200050000305
GPI class
Meclizine HCl
GCN Seq No
004731
GCN
18301
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 12.5 MG TABLET
FDB brand name
Meclizine Hcl
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 68001-528-00 — 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 → 68001-0528-00. 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
LabelerBluePoint Laboratories
FDA applicationM009 (OTC MONOGRAPH DRUG)
Labeler code68001
First marketedMar 2022
Product typeHuman Otc Drug
Portfolio347 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 12.5 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...
Patient education
Supplement & herbal interactions
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.
💬 Questions about MECLIZINE HYDROCHLORIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeRound
ImprintAB;12
Size7 mm
ScoringNot scored
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 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 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.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescolloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.031 | $3.05 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2089 | $20.89 / 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
▲ Up 2% over the last 15 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Meclizine 12.5 mg 00536-1297-01 | RUGBY | 100 tablets | $0.030 | — | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 24689-0138-01 | APNAR | 100 tablets | $0.030 | — | Availability likely | — |
| Meclizine HCl 12.5 mg 57237-0333-01 | Rising | 100 tablets | $0.030 | — | Availability likely | — |
| Meclizine HCl 12.5 mgthis 68001-0528-00 | BluePoint | 100 tablets | $0.030 | — | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 00904-7375-61 | Major | 100 tablets | $0.046 | AA | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 16571-0660-01 | Rising | 100 tablets | $0.046 | — | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 42806-0012-01 | Epic | 100 tablets | $0.046 | AA | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 50268-0522-15 | AvPAK | 50 tablets | $0.046 | AA | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 53746-0441-01 | Amneal | 100 tablets | $0.046 | AA | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 59651-0807-01 | Aurobindo | 100 tablets | $0.046 | AA | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 59746-0122-06 | Jubilant | 100 tablets | $0.046 | AA | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 60687-0775-01 | American | 100 tablets | $0.046 | AA | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 62135-0952-90 | Chartwell | 90 tablets | $0.046 | AA | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 70710-1161-00 | Zydus | 1000 tablets | $0.046 | AA | Availability likely | +52% |
| Meclizine Hydrochloride 12.5 mg 00615-8514-39 | NCS | 30 tablets | — | AA | FDA listed | — |
| Meclizine 12.5 mg 16103-0386-08 | Pharbest | 100 tablets | — | — | FDA listed | — |
| Meclizine HCL 12.5 mg 17714-0117-01 | Advance | 100 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 63629-2432-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 65162-0441-03 | Amneal | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 67296-2250-03 | Redpharm | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 68788-8633-01 | Preferred | 10 tablets | — | — | FDA listed | — |
| Meclizine HCL 12.5 mg 69618-0027-01 | Reliable | 100 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 70518-3768-00 | REMEDYREPACK | 30 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 70771-1539-00 | Zydus | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71205-0416-10 | Proficient | 10 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71205-0647-10 | Proficient | 10 tablets | — | — | FDA listed | — |
| Meclizine HCL 12.5 mg 71205-0762-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-0153-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-1563-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-1872-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-3139-01 | Bryant | 1000 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-3141-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 72162-1690-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 72189-0302-30 | DirectRx | 30 tablets | — | — | FDA listed | — |
| Meclizine 12.5 mg 73057-0386-08 | Ulai | 100 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 76420-0797-01 | Asclemed | 100 tablets | — | — | FDA listed | — |
| Meclizine 12.5 mg 80513-0427-02 | Advanced | 200 tablets | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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 68001-0528-00, 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
6.3K
Units reimbursed last 4 qtrs
303.3K
Gross reimbursed last 4 qtrs
$63.3K
Avg / prescription
$10.11
Avg / unit
$0.2089
Latest quarter Q4 2025
1.9KRx
Medicaid pays / ea
$0.2089
gross reimbursed
vs
NADAC / ea
$0.0305
acquisition cost
=
Spread
+$0.1784
+585% 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 ⓘ
Fee-for-service · 4,560 Rx Managed care · 1,708 Rx
State Medicaid map
Units reimbursed · per 100k residents
5.6363
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Meclizine HCl — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Meclizine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.73M
Claims incl. refills
748.9K
Beneficiaries
532.6K
Spend / beneficiary
$12.64
Spend / claim
$8.99
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 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 HCL (this brand).
Top reported reactions
Reporter sex
Male · 25%
Female · 75%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68001-0528-00 You're viewing this | 100 TABLET in 1 BOTTLE (68001-528-00) | 2022-03-14 | Active |
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses prevents and treats nausea, vomiting or dizziness associated with motion sickness.
⏱️ Dosage and Administration ▾
Directions dosage should be taken one hour before travel starts adults and children 12 years and over take 2 or 4 tablets once daily or as directed by a doctor
⚠️ Warnings ▾
Warnings Do not use in children under 12 years of age unless directed by a doctor.
Do not take this product, unless directed by a doctor, if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
📦 Storage and Handling ▾
Other Information store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
🧪 Active Ingredient ▾
Drug Facts Active ingredient (in each tablet) Meclizine HCl, USP 12.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose
🎯 Purpose ▾
Purpose Antiemetic
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.