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Meclizine HCl MECLIZINE HYDROCHLORIDE 12.5 mg Tablet, 100-count — NDC 68001-0528-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Meclizine HCl MECLIZINE HYDROCHLORIDE 12.5 mg Tablet, 100-count — NDC 68001-528-00 (Billing 68001-0528-00)

by BluePoint Laboratories · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Meclizine HCl MECLIZINE HYDROCHLORIDE 12.5 mg Tablet from BluePoint Laboratories, marketed since Mar 2022 and currently FDA-listed; retail pharmacies pay about $0.0313 per tablet (NADAC). It is this product's only package size.

NDC 68001-0528-00
🏷️ FDA NDC (as labeled) 68001-528-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 68001-528-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68001 labeler · 528 product · 00 package
Package marketed since
Mar 14, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 6800152800 9
Medicaid fills, this package
6,606 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 004731
  • GCN: 18301
  • GPI-14 (Medi-Span): 50200050000305
  • HICL (First Databank): 001975
  • AHFS class code: 04:04.16.00
  • RxCUI (RxNorm): 995624
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.

Clinical

Label name MECLIZINE 12.5 MG TABLET Ingredient Meclizine Hcl
📗 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.

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 $0.031 $3.13 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2249 $22.49 / 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
Aug 2022 Feb 2024 Apr 2026 Sep 2026 $0.032 $0.029
▲ Up 5% over the last 16 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68001-0528-00 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2022-03-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Meclizine 12.5 mg 00536-1297-01 RUGBY 100 tablets $0.031 — Availability likely —
Meclizine Hydrochloride 12.5 mg 24689-0138-01 APNAR 100 tablets $0.031 — Availability likely —
Meclizine HCl 12.5 mg 57237-0333-01 Rising 100 tablets $0.031 — Availability likely —
Meclizine HCl 12.5 mgthis 68001-0528-00 BluePoint 100 tablets $0.031 — Availability likely —
Meclizine Hydrochloride 12.5 mg 00904-7375-61 Major 100 tablets $0.044 AA Availability likely +41%
Meclizine Hydrochloride 12.5 mg 16571-0660-01 Rising 100 tablets $0.044 AA Availability likely +41%
Meclizine Hydrochloride 12.5 mg 50268-0522-15 AvPAK 50 tablets $0.044 AA Availability likely +41%
Meclizine Hydrochloride 12.5 mg 53746-0441-01 Amneal 100 tablets $0.044 AA Availability likely +41%
Meclizine Hydrochloride 12.5 mg 59651-0807-01 Aurobindo 100 tablets $0.044 AA Availability likely +41%
Meclizine Hydrochloride 12.5 mg 59746-0122-06 Jubilant 100 tablets $0.044 AA Availability likely +41%
Meclizine Hydrochloride 12.5 mg 60687-0775-01 American 100 tablets $0.044 AA Availability likely +41%
Meclizine Hydrochloride 12.5 mg 62135-0952-90 Chartwell 90 tablets $0.044 AA Availability likely +41%
Meclizine Hydrochloride 12.5 mg 70710-1161-00 Zydus 1000 tablets $0.044 AA Availability likely +41%
Meclizine Hydrochloride 12.5 mg 42806-0012-01 Epic 100 tablets $0.046 AA Availability likely +48%
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 — AA 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 — AA 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 — AA 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 — AA FDA listed —
Meclizine Hydrochloride 12.5 mg 71335-3139-01 Bryant 1000 tablets — AA 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 — AA 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 — AA 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.

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.

🧪 Avoiding an ingredient? See Meclizine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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.

Manufacturer & labeler

LabelerBluePoint Laboratories
FDA applicationM009 (OTC MONOGRAPH DRUG)
Labeler code68001
First marketedMar 2022
Product typeHuman Otc Drug
Portfolio347 products on file

More NDCs from BluePoint Laboratories labeler code 68001

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.

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 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Uses prevents and treats nausea, vomiting or dizziness associated with motion sickness.

⏱️ Dosage and Administration 30 words ▾

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 64 words ▾

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 15 words ▾

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

🧪 Active Ingredient 12 words ▾

Drug Facts Active ingredient (in each tablet) Meclizine HCl, USP 12.5 mg

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

🎯 Purpose 2 words ▾

Purpose Antiemetic

📄 When Using This Product 32 words ▾

When using this product do not exceed recommended dosage may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding , ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📄 Questions or Comments 14 words ▾

Questions or comments? Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

📄 Package Label / Principal Display Panel 19 words ▾

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label NDC 68001-528-00 Meclizine Hydrochloride Tablets, USP 12.5 mg 100 Tablets label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
6.6K
Units reimbursed last 4 qtrs
318.6K
Gross reimbursed last 4 qtrs
$71.7K
Avg / prescription
$10.85
Avg / unit
$0.2249
Latest quarter Q1 2026
1.8KRx
Medicaid pays / ea
$0.2249
gross reimbursed
vs
NADAC / ea
$0.0313
acquisition cost
=
Spread
+$0.1936
+619% 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 ⓘ
73% FFS 27% MCO
Fee-for-service · 4,835 Rx Managed care · 1,771 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,385 units · 99.3 per 100k residents ME Washington: 3,232 units · 41.4 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 633 units · 11.0 per 100k residents MN Wisconsin: 3,830 units · 64.8 per 100k residents WI Michigan: 9,808 units · 97.7 per 100k residents MI New York: 68,537 units · 350 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,550 units · 36.6 per 100k residents OR Nevada: 843 units · 26.4 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 3,558 units · 28.4 per 100k residents IL Indiana: 3,970 units · 57.9 per 100k residents IN Ohio: 10,039 units · 85.2 per 100k residents OH Pennsylvania: 28,502 units · 220 per 100k residents PA New Jersey: 4,406 units · 47.4 per 100k residents NJ Massachusetts: 4,107 units · 58.7 per 100k residents MA California: 138,425 units · 355 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 17,725 units · 392 per 100k residents KY West Virginia: no data reported WV Virginia: 2,081 units · 23.9 per 100k residents VA Maryland: 714 units · 11.6 per 100k residents MD Connecticut: 2,774 units · 76.7 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 940 units · 91.2 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 1,043 units · 9.5 per 100k residents GA D.C.: no data reported DC Hawaii: 2,859 units · 199 per 100k residents HI Texas: 7,688 units · 25.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
9.5392
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 Kentucky 392 /100k
2 California 355 /100k
3 New York 350 /100k
4 Pennsylvania 220 /100k
5 Hawaii 199 /100k
6 Maine 99.3 /100k
7 Michigan 97.7 /100k
8 Delaware 91.2 /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.

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.
← 68001-0527-54 · BluePoint 68001-0529-00 · BluePoint →
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.