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MECLIZINE 12.5 mg Tablet, 100-count

by RUGBY LABORATORIES · 100 TABLET in 1 BOTTLE, PLASTIC (0536-1297-01)
NDC 00536-1297-01
🏷️ FDA NDC (as labeled) 0536-1297-01 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.0305 NADAC Per package$3.05 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1921/unit · Part D plans $0.1825/unit — full pricing hub ↓
Also comes in: 1000 tablets 00536-1297-10
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 →

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) 0536-1297-01
Product NDC 0536-1297
11-digit billing NDC 00536129701
NCPDP billing unit EA — each (per item)
RxCUI 995624
UNII HDP7W44CIO
Application # M009
SPL Set ID 8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35
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 2020-05-21
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 CAPLET
FDB brand name Meclizine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1297-01 — a 4-4-2 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 labeler segment → 00536-1297-01. 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

LabelerRUGBY LABORATORIES
FDA applicationM009 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedMay 2020
Product typeHuman Otc Drug
Portfolio149 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 CAPLET 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.

💊 What it looks like

Color white
ShapeCapsule
ImprintPH049
Size13 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 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 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 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 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.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statescroscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.031 $3.05 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1921 $19.21 / 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 $0.032 $0.028
▲ Up 8% over the last 23 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 12.5 mgthis 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 mg 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

🏛️
2020
On the market since
May 2020
📍
2026
Currently FDA-listed
6 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 00536-1297-01, 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
38.6K
Units reimbursed last 4 qtrs
1.9M
Gross reimbursed last 4 qtrs
$365.3K
Avg / prescription
$9.47
Avg / unit
$0.1921
Latest quarter Q4 2025
7.2KRx
Medicaid pays / ea
$0.1921
gross reimbursed
vs
NADAC / ea
$0.0305
acquisition cost
=
Spread
+$0.1616
+530% 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 · 28,255 Rx Managed care · 10,309 Rx
State Medicaid map
Alaska: no data reported AK Maine: 17,255 units · 1,237 per 100k residents ME Washington: 37,972 units · 486 per 100k residents WA Idaho: 2,706 units · 138 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 18,116 units · 316 per 100k residents MN Wisconsin: 37,550 units · 635 per 100k residents WI Michigan: 48,718 units · 485 per 100k residents MI New York: 805,338 units · 4,115 per 100k residents NY Vermont: 2,471 units · 382 per 100k residents VT New Hampshire: 1,860 units · 133 per 100k residents NH Oregon: 7,964 units · 188 per 100k residents OR Nevada: 15,972 units · 500 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 6,527 units · 204 per 100k residents IA Illinois: 33,435 units · 266 per 100k residents IL Indiana: 8,691 units · 127 per 100k residents IN Ohio: 57,591 units · 489 per 100k residents OH Pennsylvania: 98,636 units · 761 per 100k residents PA New Jersey: 36,104 units · 389 per 100k residents NJ Massachusetts: 15,241 units · 218 per 100k residents MA California: 454,802 units · 1,167 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 12,487 units · 631 per 100k residents NE Missouri: no data reported MO Kentucky: 51,248 units · 1,132 per 100k residents KY West Virginia: no data reported WV Virginia: 23,761 units · 273 per 100k residents VA Maryland: 7,466 units · 121 per 100k residents MD Connecticut: 5,354 units · 148 per 100k residents CT Rhode Island: no data reported RI Arizona: 23,887 units · 321 per 100k residents AZ New Mexico: 993 units · 47.0 per 100k residents NM Kansas: 4,521 units · 154 per 100k residents KS Arkansas: 4,197 units · 137 per 100k residents AR Tennessee: 22 units · 0.3 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 4,124 units · 400 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: 8,341 units · 75.6 per 100k residents GA D.C.: no data reported DC Hawaii: 8,222 units · 573 per 100k residents HI Texas: 40,101 units · 131 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.34,115
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 New York 4,115 /100k
2 Maine 1,237 /100k
3 California 1,167 /100k
4 Kentucky 1,132 /100k
5 Pennsylvania 761 /100k
6 Wisconsin 635 /100k
7 Nebraska 631 /100k
8 Hawaii 573 /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 page00536-1297-01 38,564 Rx · $365,285
1000 tablets00536-1297-10 38,046 Rx · $409,328
Drug total (last 4 qtrs): 76,610 Rx · 3,826,471 units · $774,613 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00536-1297-01 You're viewing this 100 TABLET in 1 BOTTLE, PLASTIC (0536-1297-01) $0.0305 / ea $3.05 2020-05-21 Active
00536-1297-10 1000 TABLET in 1 BOTTLE, PLASTIC (0536-1297-10) $0.0305 / ea $30.45 2020-05-21 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 ($0.0305 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 50% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00536-1297-01?
NDC 00536-1297-01 is a 100-count package — 100 tablet in 1 bottle, plastic.
What is the difference between NDC 00536-1297-01 and NDC 00536-1297-10?
Both are MECLIZINE 12.5 mg Tablet — the drug itself is identical. NDC 00536-1297-01 is the 100-count package, while NDC 00536-1297-10 is the 1000 tablets package.
What NDC number is used to bill for this package of MECLIZINE 12.5 mg Tablet?
Bill NDC 00536-1297-01 — the 11-digit billing format is 00536129701. 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.

📄 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 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 caplets once daily or as directed by a doctor

⚠️ Warnings 128 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. 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, ask a health professional before use.

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).

📦 Storage and Handling 12 words ▾

Other information each caplet contains: calcium 28 mg store at 20°-25°C (68°-77°F)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each caplet) Meclizine HCl 12.5 mg

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

🎯 Purpose 2 words ▾

Purpose Antiemetic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00536-1294-31 · Rugby 00536-1298-01 · Rugby →
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.