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MECLIZINE HYDROCHLORIDE 12.5 mg Tablet, 30-count

by Direct_Rx · 30 TABLET in 1 BOTTLE (61919-886-30)
NDC 61919-0886-30
🏷️ FDA NDC (as labeled) 61919-886-30 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 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

⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 61919-886-30
Product NDC 61919-886
11-digit billing NDC 61919088630
NCPDP billing unit EA — each (per item)
Application # ANDA040659
SPL Set ID 8f0e62c6-6e50-56a8-e053-2995a90a4a38
Physiologic effect Antiemetic [EPC], Emesis Suppression
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route ORAL
Dosage form TABLET
Substance MECLIZINE HYDROCHLORIDE
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 61919-886-30 — 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 → 61919-0886-30. 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.

🏭 Manufacturer & labeler

LabelerDirect_Rx
Application holderJUBILANT CADISTA PHARMACEUTICALS INC
FDA applicationANDA040659 (ANDA)
Labeler code61919
Product typeHuman Prescription Drug
Portfolio352 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
📗 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 mg 80513-0427-02 Advanced 200 tablets — — FDA listed —
Meclizine Hydrochloride 12.5 mgthis 61919-0886-30 Direct_Rx 30 tablets — AA Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🔬 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 — the ingredient across all brands.

Top reported reactions

Dizziness1,949
Nausea1,743
Fatigue1,649
Headache1,272
Diarrhoea1,239
Fall1,194
Pain1,171

Age at onset

Neonate22
Infant8
Child2
Adolescent16
Adult1,416
Elderly1,654

Reporter sex

19,471 reports
Male · 26%
Female · 74%
Unknown · 0%

Serious outcomes

Hospitalization5,856
Death1,695
Disabling482
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,720 0
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
61919-0886-30 You're viewing this 30 TABLET in 1 BOTTLE (61919-886-30) 2019-08-01 Inactivated by FDA

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 61919-886-30, 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: 61919-0886-30, written without dashes as 61919088630. 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 61919-0886-30, the first segment (61919) is the labeler code FDA assigned to Direct_Rx; the middle segment (0886) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Direct_Rx 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 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 17 words ▾

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

⏱️ Dosage and Administration 18 words ▾

The recommended dose is 25 to 100 mg daily administered orally, in divided dosage, depending upon clinical response.

⛔ Contraindications 15 words ▾

Meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

⚠️ Warnings 61 words ▾

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 35 words ▾

Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧬 Clinical Pharmacology 190 words ▾

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 Tmax 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 ultra-rapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.

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

📦 How Supplied / Storage and Handling 110 words ▾

Meclizine hydrochloride tablets, USP are available in the following strengths and package sizes: 12.5 mg (Blue, oval shaped tablets, debossed with “TL 122” with score on one side and plain on the other side.) Bottles of 100 Bottles of 1000 25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) Bottles of 100 Bottles of 1000 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP). Keep this and all medication out of the reach of children.

Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised 01/2019

📋 Description 135 words ▾

Meclizine HCl, USP an oral antiemetic, is a white or slightly yellowish, crystalline powder. It has the following structural formula: [Structure of Meclizine HCl] Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine hydrochloride tablets, USP are available in two different strengths: 12.5 mg and 25 mg.

In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine hydrochloride tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine hydrochloride tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%). Each meclizine HCl 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base.

Each meclizine HCl 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61919-0882-28 · Direct_Rx 61919-0893-30 · DIRECT →
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.