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Meclizine Hydrochloride 12.5 mg Tablet, 50-count — NDC 50268-0522-15 package photo

Meclizine Hydrochloride 12.5 mg Tablet, 50-count

by AvPAK · 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-522-15) / 1 TABLET in 1 BLISTER PACK (50268-522-11)
NDC 50268-0522-15
🏷️ FDA NDC (as labeled) 50268-522-15 billing pads the product segment with a zero
Rx only Generic 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

Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1037-2022

🆔 Identity & classification

FDA NDC (as labeled) 50268-522-15
Product NDC 50268-522
11-digit billing NDC 50268052215
NCPDP billing unit EA — each (per item)
RxCUI 995624, 995666
UNII HDP7W44CIO
Application # ANDA201451
SPL Set ID af5d0c9b-a997-8033-afca-3c04221f2e76
Established class (EPC) Antiemetic
Physiologic effect Emesis Suppression
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-08-08
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 F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 50268-522-15 — 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 → 50268-0522-15. 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

LabelerAvPAK
Application holderAMNEAL PHARMACEUTICALS OF NEW YORK LLC
FDA applicationANDA201451 (ANDA)
Labeler code50268
First marketedAug 2013
Product typeHuman Prescription Drug
Portfolio346 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...
📖 Read our full Meclizine guide →
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.

🧪 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 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

7 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 $0.046 $2.31 / 50 tablet
Medicaid paysCMS SDUD · 12 mo $0.0234 $1.17 / 50 tablet
Medicare drug plans payPart D · Q2 2026 $0.1168 $5.84 / 50 tablet
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.092 $0.046
▼ Down 39% 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 12.5 mg 00536-1297-01 RUGBY 100 tablets $0.030 — Availability likely save 34%
Meclizine Hydrochloride 12.5 mg 24689-0138-01 APNAR 100 tablets $0.030 — Availability likely save 34%
Meclizine HCl 12.5 mg 57237-0333-01 Rising 100 tablets $0.030 — Availability likely save 34%
Meclizine HCl 12.5 mg 68001-0528-00 BluePoint 100 tablets $0.030 — Availability likely save 34%
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 mgthis 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 mg 80513-0427-02 Advanced 200 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and 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

🏛️
2013
On the market since
Aug 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 50268-0522-15, 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
96
Units reimbursed last 4 qtrs
198
Gross reimbursed last 4 qtrs
$4.63
Avg / prescription
$0.05
Avg / unit
$0.0234
Latest quarter Q1 2026
13Rx
Medicaid pays / ea
$0.0234
gross reimbursed
vs
NADAC / ea
$0.0462
acquisition cost
=
Spread
−$0.0228
-49% 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 ⓘ
42% FFS 58% MCO
Fee-for-service · 40 Rx Managed care · 56 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 83 units · 1.2 per 100k residents MA California: 31 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 84 units · 1.4 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported 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: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.11.4
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 Missouri 1.4 /100k
2 Massachusetts 1.2 /100k
3 California 0.1 /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.

🔬 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 (this brand).

Top reported reactions

Dizziness1,631
Nausea1,420
Fatigue1,369
Headache1,059
Diarrhoea1,047
Pain1,008
Fall997

Age at onset

Neonate22
Child1
Adolescent16
Adult1,197
Elderly1,492

Reporter sex

16,229 reports
Male · 26%
Female · 74%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,154 565
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 Marketing startStatus
50268-0522-15 You're viewing this 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-522-15) / 1 TABLET in 1 BLISTER PACK (50268-522-11) 2013-08-08 Active

📄 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 20 words ▾

INDICATIONS AND USAGE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.

⏱️ Dosage and Administration 32 words ▾

DOSAGE AND ADMINISTRATION For the treatment of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 mg to 100 mg daily, in divided dosage, depending upon clinical response.

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

⚠️ Warnings 62 words ▾

WARNINGS Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking this drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

🤒 Adverse Reactions 36 words ▾

ADVERSE REACTIONS Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993; email [email protected]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧬 Clinical Pharmacology 194 words ▾

CLINICAL PHARMACOLOGY Meclizine hydrochloride is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

Pharmacokinetics 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.

Metabolism The metabolic fate of meclizine in humans is unknown. 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. The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate-and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.

Elimination Meclizine has a plasma elimination half-life of about 5 to 6 hours in humans.

📦 How Supplied / Storage and Handling 160 words ▾

HOW SUPPLIED Meclizine Hydrochloride Tablets, USP 12.5 mg, are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. They are available as follows: 10 Tablets per card, 5 cards per carton: NDC 50268-522-15 Meclizine Hydrochloride Tablets, USP 25 mg, are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. They are available as follows: 10 Tablets per card, 5 cards per carton: NDC 50268-523-15 Meclizine Hydrochloride Tablets, USP 50 mg, are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep this and all medication out of the reach of children.

📋 Description 52 words ▾

DESCRIPTION Chemically, meclizinehydrochloride, USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg tablets also contain D&C Yellow #10 Aluminum Lake. Image1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50268-0521-15 · AvPAK 50268-0523-15 · AvPAK →
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.