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Meclizine Hydrochloride 25 mg Tablet, 100-count — NDC 00904-7376-61 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Meclizine Hydrochloride 25 mg Tablet, 100-count — NDC 0904-7376-61 (Billing 00904-7376-61)

by Major Pharmaceuticals · 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 100 tablets of Meclizine Hydrochloride 25 mg Tablet from Major Pharmaceuticals, marketed since Apr 2022 and currently FDA-listed; retail pharmacies pay about $0.0757 per tablet (NADAC). It is this product's only package size.

NDC 00904-7376-61
🏷️ FDA NDC (as labeled) 0904-7376-61 billing pads the labeler segment with a zero
Rx only Generic 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

⚠️
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) 0904-7376-61
Product NDC 0904-7376
11-digit billing NDC 00904737661
NCPDP billing unit EA — each (per item)
RxCUI 995624, 995666
UNII HDP7W44CIO
Application # ANDA201451
SPL Set ID f99f13ab-33c0-4304-8dc5-3a75f3909377
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 2022-04-22
Route ORAL
Dosage form TABLET
Substance MECLIZINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 50200050000310
GCN Seq No 004732
GCN 18302
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 25 MG TABLET
FDB brand name Meclizine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004732
  • GCN: 18302
  • GPI-14 (Medi-Span): 50200050000310
  • HICL (First Databank): 001975
  • AHFS class code: 04:04.16.00
  • RxCUI (RxNorm): 995624
Why two NDCs? The FDA registers this code as 0904-7376-61 — 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 → 00904-7376-61. 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 25 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 $0.076 $7.57 / 100 tablet
Medicaid paysCMS SDUD · 12 mo $0.9260 $92.60 / 100 tablet
Medicare drug plans payPart D · Q2 2026 $0.1825 $18.25 / 100 tablet
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.097 $0.076
▼ Down 22% over the last 13 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
00904-7376-61 You're viewing this Main listing 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK 2023-07-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Meclizine Hydrochloride 25 mgthis 00904-7376-61 Major 100 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 16571-0661-01 Rising 100 tablets $0.076 — Availability likely —
Meclizine Hydrochloride 25 mg 50268-0523-15 AvPAK 50 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 53746-0442-01 Amneal 100 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 59651-0808-01 Aurobindo 100 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 60687-0730-01 American 100 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 62135-0953-90 Chartwell 90 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 70710-1162-00 Zydus 1000 tablets $0.076 AA Availability likely —
Meclizine Hydrochloride 25 mg 42806-0014-01 Epic 100 tablets $0.078 AA Availability likely +3%
Meclizine Hydrochloride 25 mg 59746-0121-06 Jubilant 100 tablets $0.080 AA Availability likely +6%
Meclizine Hydrochloride 25 mg 24689-0139-01 APNAR 100 tablets $0.128 — Availability likely +69%
Meclizine Hydrochloride 25 mg 24689-0146-01 APNAR 100 tablets $0.128 — Availability likely +69%
Motion Sickness Relief 25 mg 46122-0535-51 Amerisource 8 tablets $0.128 — Availability likely +69%
Motion Sickness Relief 25 mg 70000-0097-01 Cardinal 32 tablets $0.128 — Availability likely +69%
Motion Sickness 25 mg 70677-1088-01 Strategic 8 tablets $0.128 — Availability likely +69%
Motion Sickness Relief 25 mg 00363-4030-21 Walgreen 16 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 00615-8515-39 NCS 30 tablets — AA FDA listed —
PhysiciansCare Motion Sickness 25 mg 00924-1008-00 Acme 2 tablets — — FDA listed —
Motion Sickness Relief 25 mg 11673-0356-08 TARGET 8 tablets — — FDA listed —
Less Drowsy Motion Sickness Relief 25 mg 11822-0775-09 Rite 8 tablets — — FDA listed —
Motion Sickness Relief Less Drowsy 25 mg 21130-0778-02 Better 12 tablets — — FDA listed —
Motion Sickness Relief 25 mg 30142-0943-19 Kroger 8 tablets — — FDA listed —
Motion Sickness Relief 25 mg 36800-0943-19 Topco 8 tablets — — FDA listed —
Motion Sickness 25 mg 37808-0903-12 H 100 tablets — — FDA listed —
Motion Sickness Relief 25 mg 41163-0304-02 United 12 tablets — — FDA listed —
Motion Sickness Relief 25 mg 41250-0930-19 Meijer 8 tablets — — FDA listed —
Meclizine Hydrocloride 25 mg 42708-0102-30 QPharma 30 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 42708-0127-30 QPharma 30 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 42708-0189-30 QPharma 30 tablets — AA FDA listed —
Medique Medi-Meclizine 25 mg 47682-0481-15 Unifirst 1000 tablets — — FDA listed —
Less Drowsy Motion Sickness Relief 25 mg 49035-0403-19 Wal-Mart 8 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 50090-5727-02 A-S 12 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 50090-5728-00 A-S 20 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 50090-7416-02 A-S 12 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 50090-7417-00 A-S 20 tablets — AA FDA listed —
Dramamine Less Drowsy Meclizine Hydrochloride 25 mg 50269-0526-00 JC 40 tablets — — FDA listed —
Motion Sickness Relief 25 mg 50844-0403-19 L.N.K. 8 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 51655-0107-20 Northwind 20 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 51655-0175-52 Northwind 30 tablets — AA FDA listed —
Motion Sickness 25 mg 55301-0403-21 ARMY 16 tablets — — FDA listed —
Motion Sickness Relief 25 mg 55319-0903-19 Family 8 tablets — — FDA listed —
Motion Sickness Relief 25 mg 55910-0943-19 DOLGENCORP, 8 tablets — — FDA listed —
Less Drowsy Formula Motion Sickness Relief 25 mg 57243-0403-02 Salado 12 tablets — — FDA listed —
Travel-Ease 25 mg 57896-0378-01 Geri-Care 100 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 60760-0661-30 St. 30 tablets — — FDA listed —
Dramamine Less Drowsy 25 mg 63029-0903-01 Medtech 8 tablets — — FDA listed —
Dramamine - N 25 mg 63029-0905-10 Medtech 10 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 63187-0258-10 Proficient 10 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 63187-0996-10 Proficient 10 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 65162-0442-03 Amneal 30 tablets — AA FDA listed —
Dramamine Less Drowsy, Lil Drug Store 25 mg 66715-9734-01 Lil' 2 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 67296-2138-02 Redpharm 21 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 67296-2205-02 Redpharm 21 tablets — AA FDA listed —
Dramamine Less Drowsy 25 mg 67751-0242-02 Navajo 2 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 68071-2380-02 NuCare 20 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 68071-2416-06 NuCare 6 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 68071-3017-01 NuCare 12 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 68071-3748-04 NuCare 4 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 68071-3791-02 NuCare 20 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 69842-0857-05 CVS 16 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 70518-1308-00 REMEDYREPACK 90 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 70518-3815-00 REMEDYREPACK 21 tablets — — Discontinued —
Meclizine Hydrochloride 25 mg 70771-1540-00 Zydus 1000 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 71205-0786-10 Proficient 10 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 71335-0503-00 Bryant 14 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 71335-1825-00 Bryant 14 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 72189-0237-30 Direct_Rx 30 tablets — — Discontinued —
Meclizine Hydrochloride 25 mg 76420-0130-10 Asclemed 10 tablets — AA FDA listed —
Meclizine Hydrochloride 25 mg 76420-0798-01 Asclemed 100 tablets — — FDA listed —
Nausea Relief 25 mg 79903-0177-10 WALMART 10 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 80425-0494-01 Advanced 30 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 82868-0058-20 Northwind 20 tablets — AA FDA listed —
Motion Sickness Relief 25 mg 83059-0007-01 Shield 15 tablets — — FDA listed —
Pepto Nausea Motion Sickness 25 mg 84126-0340-01 THE 10 tablets — — FDA listed —
Medique Medi-Meclizine 25 mg 85766-0175-00 Sportpharm 1000 tablets — — FDA listed —
ZenTrip Motion Sickness 25 mg 49873-0805-01 Sato 12 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 67046-0869-03 Coupler 30 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

🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 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.

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.

Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderAMNEAL PHARMACEUTICALS OF NEW YORK LLC
FDA applicationANDA201451 (ANDA)
Labeler code00904
First marketedApr 2022
Product typeHuman Prescription Drug
Portfolio630 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.

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

1 INDICATIONS AND USAGE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).

⏱️ Dosage and Administration 59 words ▾

2 DOSAGE AND ADMINISTRATION • Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ). • Tablets: Swallow whole ( 2.2 ).

2.1Recommended Dosage The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response.

2.2Administration Instructions Tablets Meclizine hydrochloride tablets must be swallowed whole.

💊 Dosage Forms and Strengths 69 words ▾

3 DOSAGE FORMS AND STRENGTHS • Meclizine hydrochloride tablets USP, 12.5 mg are light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. • Meclizine hydrochloride tablets USP, 25 mg are light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. • Tablets: 12.5 mg and 25 mg ( 3 ).

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions (6) and Description (11) ] . Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients ( 4 ).

⚠️ Warnings and Cautions 119 words ▾

5 WARNINGS AND PRECAUTIONS • May cause drowsiness: Use caution when driving a car or operating dangerous machinery ( 5.1 ). • Potential anticholinergic action: this drug should be prescribed with care to patients with a history of asthma, glaucoma, or enlargement of the prostate gland ( 5.2 ).

5.1Drowsiness Since drowsiness may occur with use of meclizine hydrochloride, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking meclizine hydrochloride [see Drug Interactions (7.1) ].

5.2Concurrent Medical Conditions Because of its potential anticholinergic action, meclizine hydrochloride should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

🤒 Adverse Reactions 111 words ▾

6 ADVERSE REACTIONS The following adverse reactions associated with the use of meclizine hydrochloride were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting.

On rare occasions blurred vision has been reported. Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 112 words ▾

7 DRUG INTERACTIONS • Co-administration of meclizine hydrochloride with other CNS depressants, including alcohol, may result in increased CNS depression ( 7.1 ). • CYP2D6 inhibitors: As meclizine is metabolized by CYP2D6, there is a potential for drug-drug interactions between meclizine hydrochloride and CYP2D6 inhibitors ( 7.2 ).

7.1CNS Depressants There may be increased CNS depression when meclizine hydrochloride is administered concurrently with other CNS depressants, including alcohol [see Warnings and Precautions (5.1) ] .

7.2CYP2D6 Inhibitors Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore, there is a possibility for a drug interaction between meclizine hydrochloride and CYP2D6 inhibitors. Therefore, monitor for adverse reactions and clinical effect accordingly.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data Epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects. Animal Data In a published study, oral administration of meclizine (25 mg/kg to 250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations.

These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m 2 ) basis.

8.2Lactation Risk Summary There are no data on the presence of meclizine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for meclizine hydrochloride and any potential adverse effects on the breastfed infant from meclizine hydrochloride or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As meclizine hydrochloride undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine. Treatment with meclizine hydrochloride should be administered with caution in patients with hepatic impairment.

8.7Renal Impairment The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Because of a potential for drug/metabolite accumulation, meclizine hydrochloride should be administered with caution in patients with renal impairment and in the elderly, as renal function generally declines with age.

8.8Genetic CYP2D6 Polymorphism The genetic polymorphism of CYP2D6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. Therefore, when meclizine hydrochloride is administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

🤰 Pregnancy 192 words ▾

8.1Pregnancy Risk Summary Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data Epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects. Animal Data In a published study, oral administration of meclizine (25 mg/kg to 250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations.

These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m 2 ) basis.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 43 words ▾

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🧬 Clinical Pharmacology 141 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism by which meclizine exerts its therapeutic effect is unknown but is presumed to involve antagonism of the histamine H1 receptor.

12.2Pharmacodynamics There are no relevant pharmacodynamic data regarding meclizine.

12.3Pharmacokinetics 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.

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

🧬 Mechanism of Action 27 words ▾

12.1Mechanism of Action The precise mechanism by which meclizine exerts its therapeutic effect is unknown but is presumed to involve antagonism of the histamine H1 receptor.

📦 How Supplied / Storage and Handling 175 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How 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: Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-7375-61 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: Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-7376-61 WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only.

Keep this and all drugs out of the reach of children.

16.2Storage and Handling 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 137 words ▾

11 DESCRIPTION Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. Its molecular formula is C 25 H 27 ClN 2 .2HCl.H 2 O and its molecular weight is 481.88. It has the following structural formula: Chemically, meclizine hydrochloride is 1-( p -chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate.

Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. 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. 1

💬 Information for Patients 200 words ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Advise patients that the tablets must be swallowed whole [see Dosage and Administration (2.1) ]. Adverse Reactions Advise patients that meclizine hydrochloride may cause anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision [see Warnings and Precautions (5.1) , Adverse Reactions (6) ]. Inform patients that meclizine hydrochloride may impair their ability to engage in potentially dangerous activities, such as operating machinery or vehicles.

Concomitant Drug Interactions Advise patients regarding medications that should not be taken in combination with meclizine hydrochloride or that may necessitate increased monitoring [see Drug Interactions (7.1 , 7.2 )]. Inform patients that alcohol may increase adverse reactions. Concurrent Medical Conditions Advise patients to notify their healthcare provider about all of their medical conditions, including if they are pregnant or plan to become pregnant or if they are breastfeeding [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1 , 8.2 )] .

Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Rev.

03-2026-02

🧬 Pharmacokinetics 101 words ▾

12.3Pharmacokinetics 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.

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

🧬 Pharmacodynamics 10 words ▾

12.2Pharmacodynamics There are no relevant pharmacodynamic data regarding meclizine.

🧪 Nonclinical Toxicology 54 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Animal studies to assess the carcinogenic potential of meclizine have not been conducted. Mutagenesis Genetic toxicology studies of meclizine have not been conducted. Impairment of Fertility Animal studies to assess the effects of meclizine on fertility and early embryonic development have not been conducted.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 51 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Animal studies to assess the carcinogenic potential of meclizine have not been conducted. Mutagenesis Genetic toxicology studies of meclizine have not been conducted. Impairment of Fertility Animal studies to assess the effects of meclizine on fertility and early embryonic development have not been conducted.

📄 Package Label / Principal Display Panel 48 words ▾

Package/Label Display Panel MAJOR® NDC 0904-7375-61 Unit Dose Meclizine Hydrochloride Tablets, USP 12.5 mg* 100 TABLETS (10 x 10) Rx only 12.5mg carton label

Package/Label Display Panel MAJOR® NDC 0904-7376-61 Unit Dose Meclizine Hydrochloride Tablets, USP 25 mg* 100 TABLETS (10 x 10) Rx only 25mg carton 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 – 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
1.8K
Units reimbursed last 4 qtrs
35.2K
Gross reimbursed last 4 qtrs
$32.6K
Avg / prescription
$17.84
Avg / unit
$0.9260
Latest quarter Q4 2025
405Rx
Medicaid pays / ea
$0.9260
gross reimbursed
vs
NADAC / ea
$0.0757
acquisition cost
=
Spread
+$0.8503
+1123% 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 ⓘ
48% FFS 52% MCO
Fee-for-service · 871 Rx Managed care · 958 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: 30,648 units · 157 per 100k residents NY Vermont: 48 units · 7.4 per 100k residents VT New Hampshire: 94 units · 6.7 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 29 units · 3.2 per 100k residents SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 134 units · 1.1 per 100k residents OH Pennsylvania: 12 units · 0.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 3,653 units · 9.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 100 units · 1.6 per 100k residents MO Kentucky: 522 units · 11.5 per 100k residents 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
0.1157
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 157 /100k
2 Kentucky 11.5 /100k
3 California 9.4 /100k
4 Vermont 7.4 /100k
5 New Hampshire 6.7 /100k
6 South Dakota 3.2 /100k
7 Missouri 1.6 /100k
8 Ohio 1.1 /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.
← 00904-7375-61 · Major 00904-7378-40 · Major →
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.