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MECLIZINE 12.5 mg Tablet, 200-count — NDC 80513-0427-02 package photo

MECLIZINE 12.5 mg Tablet, 200-count

by Advanced Rx LLC · 200 TABLET in 1 BOTTLE, PLASTIC (80513-427-02)
NDC 80513-0427-02
🏷️ FDA NDC (as labeled) 80513-427-02 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 →

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) 80513-427-02
Product NDC 80513-427
11-digit billing NDC 80513042702
RxCUI 995624
UNII HDP7W44CIO
UPC 0380513000316
Application # M009
SPL Set ID 032a89f2-17e7-45d2-94a1-cc7a601ebdee
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 2025-09-01
Route ORAL
Dosage form TABLET
Substance MECLIZINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 80513-427-02 — 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 → 80513-0427-02. 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

LabelerAdvanced Rx LLC
FDA applicationM009 (OTC MONOGRAPH DRUG)
Labeler code80513
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio39 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

📗 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1825 $36.50 / 200 tablets
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 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 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 —
Meclizine Hydrochloride 12.5 mg 16571-0660-01 Rising 100 tablets $0.046 — Availability likely —
Meclizine Hydrochloride 12.5 mg 42806-0012-01 Epic 100 tablets $0.046 AA Availability likely —
Meclizine Hydrochloride 12.5 mg 50268-0522-15 AvPAK 50 tablets $0.046 AA Availability likely —
Meclizine Hydrochloride 12.5 mg 53746-0441-01 Amneal 100 tablets $0.046 AA Availability likely —
Meclizine Hydrochloride 12.5 mg 59651-0807-01 Aurobindo 100 tablets $0.046 AA Availability likely —
Meclizine Hydrochloride 12.5 mg 59746-0122-06 Jubilant 100 tablets $0.046 AA Availability likely —
Meclizine Hydrochloride 12.5 mg 60687-0775-01 American 100 tablets $0.046 AA Availability likely —
Meclizine Hydrochloride 12.5 mg 62135-0952-90 Chartwell 90 tablets $0.046 AA Availability likely —
Meclizine Hydrochloride 12.5 mg 70710-1161-00 Zydus 1000 tablets $0.046 AA Availability likely —
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 mgthis 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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80513-0427-02 You're viewing this 200 TABLET in 1 BOTTLE, PLASTIC (80513-427-02) 2025-09-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 80513-427-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 80513-0427-02, written without dashes as 80513042702. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 80513-0427-02, the first segment (80513) is the labeler code FDA assigned to Advanced Rx LLC; the middle segment (0427) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 1 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 124 words ▾

Warnings Do not use in children under 12 years of age unless directed by a doctor. Do not take 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 if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful 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 28 words ▾

Other information Tamper Evident: do not use if safety seal under cap is broken or missing each caplet contains: calcium 28 mg store at room temperature 20°-25°C (68°-77°F).

🧪 Active Ingredient 8 words ▾

Active ingredient (in each caplet) Meclizine HCl 12.5mg

🧪 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 ↗
← 80513-0421-02 · Advanced 80513-0506-01 · Advanced →
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.