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Levocetirizine Dihydrochloride 5 mg Tablet, 500-count — NDC 68462-0346-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Levocetirizine Dihydrochloride 5 mg Tablet, 500-count — NDC 68462-346-05 (Billing 68462-0346-05)

by Glenmark Pharmaceuticals Inc., USA · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of Levocetirizine Dihydrochloride 5 mg Tablet from Glenmark Pharmaceuticals Inc., USA, marketed since Feb 2011 and currently FDA-listed.

NDC 68462-0346-05
🏷️ FDA NDC (as labeled) 68462-346-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Product page 68462-0346-90 Also comes in: 90 tablets 68462-346-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68462-346-05
Product NDC 68462-346
11-digit billing NDC 68462034605
RxCUI 855172
UNII SOD6A38AGA
UPC 0368462346907
Application # ANDA090385
SPL Set ID 60ae7e0e-281c-40a3-a0d3-259b843ddaaa
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-02-25
Route ORAL
Dosage form TABLET
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 048920
GCN 14901
HICL code 022959
Ingredient (HICL) Levocetirizine Dihydrochloride
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2Q
Therapeutic class — specific (HIC3) Antihistamines - 2Nd Generation
AHFS code 04:08.00.00
AHFS class Second Generation Antihistamines
FDB label name LEVOCETIRIZINE 5 MG TABLET
FDB brand name Levocetirizine Dihydrochloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048920
  • GCN: 14901
  • HICL (First Databank): 022959
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 855172
Why two NDCs? The FDA registers this code as 68462-346-05 — 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 → 68462-0346-05. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Piperazine derivatives
How it works Histamine H1 Receptor Antagonists
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 LEVOCETIRIZINE 5 MG TABLET Ingredient Levocetirizine Dihydrochloride
📗 Our plain-language guide HelloPharmacist
  • Levocetirizine treats seasonal and perennial allergic rhinitis — basically hay fever and year-round indoor allergies — relieving symptoms like runny nose, sneezing, and itchy, wate...
  • It can, yes — drowsiness is the most commonly reported side effect and tends to be more noticeable at higher doses. That's why it's recommended to take it in the evening. Until you...
  • Yes, you can take levocetirizine with or without food — it's flexible that way. If you take the tablet with a high-fat meal, it might take a little longer to kick in and the peak l...
  • This is an important one to flag with your doctor before you start. Levocetirizine is mainly cleared from your body through the kidneys, so if your kidney function is reduced, the...
📖 Read our full Levocetirizine 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.

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.
Try another pack size: 90 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
68462-0346-90 68462-346-90 Main listing 90 TABLET in 1 BOTTLE $0.0511 / ea $4.60 2011-02-25 — Active
68462-0346-05 You're viewing this 500 TABLET in 1 BOTTLE — — 2026-09-01 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 90 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 68462-0346-90?
Both are Levocetirizine Dihydrochloride 5 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 68462-0346-90 is the 90 tablets package.
What NDC number is used to bill for this package of Levocetirizine Dihydrochloride 5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levocetirizine Dihydrochloride 5 mg 00093-7701-98 Teva 90 tablets $0.051 AB Availability likely —
Levocetirizine Dihydrochloride 5 mg 69367-0238-09 Westminster 90 tablets $0.051 AB Availability likely —
Allergy Relief 5 mg 46122-0531-05 AMERISOURCEBERGEN 35 tablets $0.218 — Availability likely —
24HR Allergy Relief 5 mg 70000-0362-01 LEADER/ 5 tablets $0.218 — Availability likely —
good sense levocetirizine 5 mg 00113-0241-01 L. 35 tablets — — FDA listed —
allergy relief 5 mg 00363-3901-01 Walgreen 35 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 00363-5529-10 Walgreens 5 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 00615-8565-39 NCS 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 10135-0639-30 Marlex 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 11673-0847-16 Target 80 tablets — — FDA listed —
allergy relief 5 mg 11822-0241-00 Rite 35 tablets — — Discontinued —
levocetirizine dihydrochloride 5 mg 11822-5252-01 Rite 120 tablets — — FDA listed —
Allergy Relief 5 mg 21130-0732-10 Albertsons 5 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 30142-0717-16 KROGER 80 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 31722-0551-05 Camber 500 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 33342-0200-07 Macleods 30 tablets — AB FDA listed —
Topcare All Day Allergy 5 mg 36800-0241-01 Topco 35 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 37808-0126-10 HEB 5 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 41163-0938-35 United 35 tablets — — FDA listed —
Xyzal Allergy 24HR 5 mg 41167-3510-00 Chattem, 10 tablets — — FDA listed —
Xyzal Allergy 24HR 5 mg 41167-3511-02 Chattem, 20 tablets — — FDA listed —
Xyzal Allergy 24HR 5 mg 41167-3513-04 Chattem, 90 tablets — — FDA listed —
Xyzal 5 mg 41167-5803-09 Chattem, 90 tablets — — FDA listed —
Allergy Relief 5 mg 41250-0488-01 Meijer 35 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 42543-0712-03 Vensun 300 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 42571-0122-05 Micro 500 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 42571-0312-11 Micro 1000 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 43063-0479-30 PD-Rx 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 43598-0735-22 Dr. 55 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 43598-0810-76 Dr. 80 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 49035-0492-35 Walmart 35 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 50090-1430-00 A-S 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 50090-6979-00 A-S 90 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 50228-0136-10 ScieGen 1000 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 51407-0892-90 Golden 90 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 51655-0148-52 Northwind 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 51655-0564-52 Northwind 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 55111-0282-01 Dr.Reddy's 100 tablets — AB FDA listed —
DG Health Allergy Relief 5 mg 55910-0241-46 Dolgencorp, 1 tablet — — FDA listed —
levocetirizine dihydrochloride 5 mg 63187-0663-30 Proficient 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 63629-8500-01 Bryant 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 63868-0473-35 Chain 35 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 68071-2406-09 NuCare 90 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 68071-3726-09 NuCare 90 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 68071-3841-09 NuCare 90 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 68071-5107-09 NuCare 90 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 68196-0406-20 SAM'S 200 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 68391-0955-11 BJWC 55 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mgthis 68462-0346-05 Glenmark 500 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 68788-7934-01 Preferred 100 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 68788-8810-01 Preferred 100 tablets — AB FDA listed —
Allery Relief 24HR 5 mg 69168-0451-06 Allegiant 120 tablets — — FDA listed —
Levocetirizine dihydrochloride 5 mg 69230-0321-01 Camber 10 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 69842-0761-10 CVS 5 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 71205-0210-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71205-0476-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71205-0988-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71335-0418-01 Bryant 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71335-0789-01 Bryant 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 71335-0940-01 Bryant 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71335-1305-01 Bryant 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 71335-1952-01 Bryant 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 71335-2283-01 Bryant 10 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 72162-1525-03 Bryant 30 tablets — AB FDA listed —
basic care allergy relief 5 mg 72288-0241-27 Amazon.com 80 tablets — — FDA listed —
Curist Allergy Relief 5 mg 72559-0021-05 Little 90 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 72789-0023-30 PD-Rx 30 tablets — AB FDA listed —
Allergy Relief 5 mg 73581-0201-80 YYBA 180 tablets — — FDA listed —
Allergy Relief 24HR 5 mg 76168-0501-10 VELOCITY 10 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 82804-0204-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 82804-0232-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 85766-0152-35 Sportpharm 35 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 85786-0206-30 Farmacias 15 tablets — — FDA listed —
Allergy Relief 5 mg 72288-0784-27 Amazon.com 80 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

🏛️
2011
On the market since
Feb 2011
📍
2026
Currently FDA-listed
15 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.

What it looks like

Color White
ShapeOval
ImprintG;Breakline;G
Size8 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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.

Manufacturer & labeler

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA090385 (ANDA)
Labeler code68462
First marketedFeb 2011
Product typeHuman Prescription Drug
Portfolio343 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 103 words ▾

1 INDICATIONS AND USAGE Levocetirizine dihydrochloride tablets are a histamine H 1 -receptor antagonist indicated for: • The relief of symptoms associated with perennial allergic rhinitis ( 1.1 ) • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 )

1.1Perennial Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age.

1.2Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption. Chronic Idiopathic Urticaria ( 2.2 ) • Adults and children 12 years of age and older: 5 mg once daily in the evening • Children 6 to 11 years of age: 2.5 mg once daily in the evening • Renal Impairment Adjust the dose in patients 12 years of age and older with decreased renal function ( 12.3 )

2.2Chronic Idiopathic Urticaria Adults and Children 12 Years of Age and Older The recommended dose of levocetirizine dihydrochloride tablets is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening. Children 6 to 11 Years of Age The recommended dose of levocetirizine dihydrochloride tablets is 2.5 mg (1/2 tablet) once daily in the evening.

The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [ see Clinical Pharmacology ( 12.3 ) ]. Dose Adjustment for Renal and Hepatic Impairment In adults and children 12 years of age and older with: • Mild renal impairment (creatinine clearance [CL CR ] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; • Moderate renal impairment (CL CR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; • Severe renal impairment (CL CR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended; • End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.

No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS Levocetirizine Dihydrochloride Tablets, USP are white, oval, film-coated, biconvex tablets, one side embossed with 'G' break line ‘G’ and the other side plain and contain 5 mg levocetirizine dihydrochloride, USP. • Immediate release breakable (scored) tablets, 5 mg (3)

⛔ Contraindications 146 words ▾

4 CONTRAINDICATIONS The use of levocetirizine dihydrochloride tablets are contraindicated in: • Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets or to cetirizine ( 4.1 ) • Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis ( 4.2 ) • Children 6 months to 11 years of age with renal impairment ( 4.3 )

4.1Patients with Known Hypersensitivity Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [ see Adverse Reactions ( 6.2 ) ].

4.2Patients with End-Stage Renal Disease Patients with end-stage renal disease (CL CR < 10 mL/min) and patients undergoing hemodialysis

4.3Pediatric Patients with Impaired Renal Function Children 6 months to 11 years of age with impaired renal function

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking levocetirizine dihydrochloride ( 5.1 ). • Avoid concurrent use of alcohol or other central nervous system depressants with levocetirizine dihydrochloride ( 5.1 ). • Use with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia). Discontinue levocetirizine dihydrochloride if urinary retention occurs ( 5.2 ). • Risk of New Onset Pruritus After Discontinuation of levocetirizine dihydrochloride : New onset pruritus within a few days after discontinuation of levocetirizine dihydrochloride has been reported, usually after long-term use (e.g., few months to years) of levocetirizine dihydrochloride Symptoms may improve with restarting or tapering levocetirizine dihydrochloride ( 5.3 ).

5.1Somnolence In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with levocetirizine dihydrochloride. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride. Concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.

5.2Urinary Retention Urinary retention has been reported postmarketing with levocetirizine dihydrochloride. Levocetirizine dihydrochloride should be used with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine dihydrochloride may increase the risk of urinary retention. Discontinue levocetirizine dihydrochloride if urinary retention occurs.

5.3Risk of New Onset Pruritus After Discontinuation of Levocetirizine Dihydrochloride Tablets Cases of pruritus after discontinuation of levocetirizine dihydrochloride tablets have been reported in the postmarketing setting in patients where pruritus was not present before initiation of Levocetirizine dihydrochloride tablets. Pruritus occurred within a few days of discontinuing levocetirizine dihydrochloride tablets among patients who used levocetirizine dihydrochloride tablets long-term (e.g., few months to years).

Reported cases of pruritus were infrequent, but some were serious with patients experiencing widespread severe pruritus [see Adverse Reactions ( 6.2 )] . If pruritus occurs after discontinuation of levocetirizine dihydrochloride tablets, symptoms may improve with restarting or tapering levocetirizine dihydrochloride tablets.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Somnolence [see Warnings and Precautions ( 5.1 )] • Urinary Retention [see Warnings and Precautions ( 5.2 )] • Risk of New Onset Pruritus After Discontinuation of Levocetirizine Dihydrochloride [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (rate ≥2% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age.

In subjects 1 to 5 years of age, the most common adverse reactions (rate ≥2% and > placebo) were pyrexia, diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of age, the most common adverse reactions (rate ≥3% and > placebo) were diarrhea and constipation. ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience The safety data described below reflect exposure to levocetirizine dihydrochloride in 2708 patients with allergic rhinitis or chronic idiopathic urticaria in 14 controlled clinical trials of 1 week to 6 months duration. The short-term (exposure up to 6 weeks) safety data for adults and adolescents are based upon eight clinical trials in which 1896 patients (825 males and 1071 females aged 12 years and older) were treated with levocetirizine dihydrochloride 2.5, 5, or 10 mg once daily in the evening.

The short-term safety data from pediatric patients are based upon two clinical trials in which 243 children with allergic rhinitis (162 males and 81 females 6 to 12 years of age) were treated with levocetirizine dihydrochloride 5 mg once daily for 4 to 6 weeks, one clinical trial in which 114 children (65 males and 49 females 1 to 5 years of age) with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine dihydrochloride 1.25 mg twice daily for 2 weeks, and one clinical trial in which 45 children (28 males and 17 females 6 to 11 months of age) with symptoms of allergic rhinitis or chronic urticaria were treated with levocetirizine dihydrochloride 1.25 mg once daily for 2 weeks.

The long-term (exposure of 4 or 6 months) safety data in adults and adolescents are based upon two clinical trials in which 428 patients (190 males and 238 females) with allergic rhinitis were exposed to treatment with levocetirizine dihydrochloride 5 mg once daily. Long term safety data are also available from an 18-month trial in 255 levocetirizine dihydrochloride-treated subjects 12 to 24 months of age. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 years of Age and Older In studies up to 6 weeks in duration, the mean age of the adult and adolescent patients was 32 years, 44% of the patients were men and 56% were women, and the large majority (more than 90%) was Caucasian. In these trials 43% and 42% of the subjects in the levocetirizine dihydrochloride 2.5 mg and 5 mg groups, respectively, had at least one adverse event compared to 43% in the placebo group. In placebo-controlled trials of 1 to 6 weeks in duration, the most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis, and most were mild to moderate in intensity.

Somnolence with levocetirizine dihydrochloride showed dose ordering between tested doses of 2.5, 5 and 10 mg and was the most common adverse reaction leading to discontinuation (0.5%). Table 1 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 12 years and older exposed to levocetirizine dihydrochloride 2.5 mg or 5 mg in eight placebo-controlled clinica… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 142 words ▾

7 DRUG INTERACTIONS In vitro data indicate that levocetirizine is unlikely to produce pharmacokinetic interactions through inhibition or induction of liver drug-metabolizing enzymes. No in vivo drug-drug interaction studies have been performed with levocetirizine. Drug interaction studies have been performed with racemic cetirizine.

7.1Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline, and Pseudoephedrine Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. There was a small decrease (~16%) in the clearance of cetirizine caused by a 400 mg dose of theophylline. It is possible that higher theophylline doses could have a greater effect.

7.2Ritonavir Ritonavir increased the plasma AUC of cetirizine by about 42% accompanied by an increase in half-life (53%) and a decrease in clearance (29%) of cetirizine. The disposition of ritonavir was not altered by concomitant cetirizine administration.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Renal Impairment Because levocetirizine dihydrochloride is substantially excreted by the kidneys, the risk of adverse reactions to this drug may be greater in patients with impaired renal function ( 8.6 , 12.3 ). • Pediatric Use Do not exceed the recommended dose of 2.5 mg once daily in children 6 to 11 years of age. Systemic exposure with these doses in respective pediatric age groups is comparable to that from a 5 mg once daily dose in adults. ( 12.3 ).

8.1Pregnancy Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral route to pregnant rats and rabbits, during the period of organogenesis, at doses up to 390 times and 470 times, respectively, the maximum recommended human dose (MRHD) in adults.

In rats treated during late gestation and the lactation period, cetirizine had no effects on pup development at oral doses up to approximately 60 times the MRHD in adults. In mice treated during late gestation and the lactation period, cetirizine administered by the oral route to the dams had no effects on pup development at a dose that was approximately 25 times the MRHD in adults; however, lower pup weight gain during lactation was observed at a dose that was 95 times the MRHD in adults (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryo-fetal development studies, pregnant rats received daily doses of levocetirizine up to 200 mg/kg/day from gestation days 6 to 15 and pregnant rabbits received daily doses of levocetirizine up to 120 mg/kg/day from gestation days 6 to 18.

Levocetirizine produced no evidence of fetal harm in rats and rabbits at doses up to 390 and 470 times the MRHD, respectively (on a mg/m 2 basis with maternal oral doses of 200 and 120 mg/kg/day in rats and rabbits, respectively). No prenatal and postnatal development (PPND) studies in animals have been conducted with levocetirizine. In a PPND study conducted in mice, cetirizine was administered at oral doses up to 96 mg/kg/day from gestation day 15 through lactation day 21.

Cetirizine lowered pup body weight gain during lactation at an oral dose in dams that was approximately 95 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 96 mg/kg/day); however, there were no effects on pup weight gain at an oral dose in dams that was approximately 25 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 24 mg/kg/day). In a PPND study conducted in rats, cetirizine was administered at oral doses up to 180 mg/kg/day from gestation day 17 to lactation day 22. Cetirizine did not have any adverse effects on rat dams or offspring development at doses up to approximately 60 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 30 mg/kg/day).

Cetirizine caused excessive maternal toxicity at an oral dose in dams that was approximately 350 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 180 mg/kg/day).

8.2Lactation Risk Summary There are no data on the presence of levocetirizine in human milk, the effects on the breastfed infant, or the effects on milk production. However, cetirizine has been reported to be present in human breast milk. In mice and beagle dogs, studies indicated that cetirizine was excreted in milk (see Data) .

When a drug is present in animal milk, it is likely the drug will be present in human milk. The developmental and… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral route to pregnant rats and rabbits, during the period of organogenesis, at doses up to 390 times and 470 times, respectively, the maximum recommended human dose (MRHD) in adults.

In rats treated during late gestation and the lactation period, cetirizine had no effects on pup development at oral doses up to approximately 60 times the MRHD in adults. In mice treated during late gestation and the lactation period, cetirizine administered by the oral route to the dams had no effects on pup development at a dose that was approximately 25 times the MRHD in adults; however, lower pup weight gain during lactation was observed at a dose that was 95 times the MRHD in adults (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryo-fetal development studies, pregnant rats received daily doses of levocetirizine up to 200 mg/kg/day from gestation days 6 to 15 and pregnant rabbits received daily doses of levocetirizine up to 120 mg/kg/day from gestation days 6 to 18.

Levocetirizine produced no evidence of fetal harm in rats and rabbits at doses up to 390 and 470 times the MRHD, respectively (on a mg/m 2 basis with maternal oral doses of 200 and 120 mg/kg/day in rats and rabbits, respectively). No prenatal and postnatal development (PPND) studies in animals have been conducted with levocetirizine. In a PPND study conducted in mice, cetirizine was administered at oral doses up to 96 mg/kg/day from gestation day 15 through lactation day 21.

Cetirizine lowered pup body weight gain during lactation at an oral dose in dams that was approximately 95 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 96 mg/kg/day); however, there were no effects on pup weight gain at an oral dose in dams that was approximately 25 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 24 mg/kg/day). In a PPND study conducted in rats, cetirizine was administered at oral doses up to 180 mg/kg/day from gestation day 17 to lactation day 22. Cetirizine did not have any adverse effects on rat dams or offspring development at doses up to approximately 60 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 30 mg/kg/day).

Cetirizine caused excessive maternal toxicity at an oral dose in dams that was approximately 350 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 180 mg/kg/day).

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The recommended dose of levocetirizine dihydrochloride for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older [see Clinical Studies ( 14 )]. The recommended dose of levocetirizine dihydrochloride in patients 6 months to 2 years of age for the treatment of the symptoms of perennial allergic rhinitis and 6 months to 11 years of age with chronic idiopathic urticaria is based on cross-study comparisons of the systemic exposure of levocetirizine dihydrochloride in adults and pediatric patients and on the safety profile of levocetirizine dihydrochloride in both adult and pediatric patients at doses equal to or higher than the recommended dose for patients 6 months to 11 years of age.

The safety of levocetirizine dihydrochloride 5 mg once daily was evaluated in 243 pediatric patients 6 to 12 years of age in two placebo-controlled clinical trials lasting 4 and 6 weeks. The safety of levocetirizine dihydrochloride 1.25 mg twice daily was evaluated in one 2-week clinical trial in 114 pediatric patients 1 to 5 years of age and the safety of levocetirizine dihydrochloride 1.25 mg once daily was evaluated in one 2-week clinical trial in 45 pediatric patients 6 to 11 months of age [see Adverse Reactions ( 6.1 )].

The effectiveness of levocetirizine dihydrochloride 1.25 mg once daily (6 months to 5 years of age) and 2.5 mg once daily (6 to 11 years of age) for the treatment of the symptoms of perennial allergic rhinitis and chronic idiopathic urticaria is supported by the extrapolation of demonstrated efficacy of levocetirizine dihydrochloride 5 mg once daily in patients 12 years of age and older based on the pharmacokinetic comparison between adults and children. Cross-study comparisons indicate that administration of a 5 mg dose of levocetirizine dihydrochloride to 6 to 12 year old pediatric patients resulted in about 2-fold the systemic exposure (AUC) observed when 5 mg of levocetirizine dihydrochloride was administered to healthy adults.

Therefore, in children 6 to 11 years of age the recommended dose of 2.5 mg once daily should not be exceeded. In a population pharmacokinetics study the administration of 1.25 mg once daily in children 6 months to 5 years of age resulted in systemic exposure comparable to 5 mg once daily in adults. [see Dosage and Administration ( 2.2 ), Clinical Studies ( 14 ), and Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 194 words ▾

10 OVERDOSAGE Overdosage has been reported with levocetirizine dihydrochloride. Symptoms of overdose may include drowsiness in adults. In children agitation and restlessness may initially occur, followed by drowsiness.

There is no known specific antidote to levocetirizine dihydrochloride. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine dihydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.

The acute maximal non-lethal oral dose of levocetirizine was 240 mg/kg in mice (approximately 190 times the maximum recommended daily oral dose in adults, approximately 230 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 180 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m 2 basis). In rats the maximal non-lethal oral dose was 240 mg/kg (approximately 390 times the maximum recommended daily oral dose in adults, approximately 460 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 370 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m 2 basis).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H 1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. In vitro binding studies revealed that levocetirizine has an affinity for the human H 1 -receptor 2-fold higher than that of cetirizine (Ki = 3 nmol/L vs.

6 nmol/L, respectively). The clinical relevance of this finding is unknown.

12.2Pharmacodynamics Studies in adult healthy subjects showed that levocetirizine at doses of 2.5 mg and 5 mg inhibited the skin wheal and flare caused by the intradermal injection of histamine. In contrast, dextrocetirizine exhibited no clear change in the inhibition of the wheal and flare reaction. Levocetirizine at a dose of 5 mg inhibited the wheal and flare caused by intradermal injection of histamine in 14 pediatric subjects (aged 6 to 11 years) and the activity persisted for at least 24 hours.

The clinical relevance of histamine wheal skin testing is unknown. A QT/QTc study using a single dose of 30 mg of levocetirizine did not demonstrate an effect on the QTc interval. While a single dose of levocetirizine had no effect, the effects of levocetirizine may not be at steady state following single dose.

The effect of levocetirizine on the QTc interval following multiple dose administration is unknown. Levocetirizine is not expected to have QT/QTc effects because of the results of QTc studies with cetirizine and the long postmarketing history of cetirizine without reports of QT prolongation.

12.3Pharmacokinetics Levocetirizine exhibited linear pharmacokinetics over the therapeutic dose range in adult healthy subjects. Absorption Levocetirizine is rapidly and extensively absorbed following oral administration. In adults, peak plasma concentrations are achieved 0.9 hour after administration of the oral tablet.

The accumulation ratio following daily oral administration is 1.12 with steady state achieved after 2 days. Peak concentrations are typically 270 ng/mL and 308 ng/mL following a single and a repeated 5 mg once daily dose, respectively. Food had no effect on the extent of exposure (AUC) of the levocetirizine tablet, but T max was delayed by about 1.25 hours and C max was decreased by about 36% after administration with a high fat meal; therefore, levocetirizine can be administered with or without food.

A dose of 5 mg (10 mL) of levocetirizine dihydrochloride oral solution is bioequivalent to a 5 mg dose of levocetirizine dihydrochloride tablets. Following oral administration of a 5 mg dose of levocetirizine dihydrochloride oral solution to healthy adult subjects, the mean peak plasma concentrations were achieved approximately 0.5 hour post dose. Distribution The mean plasma protein binding of levocetirizine in vitro ranged from 91 to 92%, independent of concentration in the range of 90 to 5000 ng/mL, which includes the therapeutic plasma levels observed.

Following oral dosing, the average apparent volume of distribution is approximately

0.4L/kg, representative of distribution in total body water. Metabolism The extent of metabolism of levocetirizine in humans is less than 14% of the dose and therefore differences resulting from genetic polymorphism or concomitant intake of hepatic drug metabolizing enzyme inhibitors are expected to be negligible. Metabolic pathways include aromatic oxidation, N- and O-dealkylation, and taurine conjugation.

Dealkylation pathways are primarily mediated by CYP3A4 while aromatic oxidation involves multiple and/or unidentified CYP isoforms. Elimination The plasma half-life in adult healthy subjects was about 8 to 9 hours after administration of oral tablets and oral solution, and the mean oral total body clearance for levocetirizine was approximately 0.63 mL/kg/min. The major route of excretion of levocetirizine and its metabolites is via urine, accounting for… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 129 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Levocetirizine Dihydrochloride Tablets, USP are white, oval, film-coated biconvex tablets, one side embossed with ‘G’ break line ‘G’ and the other side plain and contain 5 mg levocetirizine dihydrochloride, USP. They are available as follows: HDPE bottles of 30 tablets with child-resistant closures (NDC 68462-346-30) HDPE bottles of 90 tablets with child-resistant closures (NDC 68462-346-90) HDPE bottles of 180 tablets with child-resistant closures (NDC 68462-346-18) HDPE bottles of 500 tablets with continuous thread closures (NDC 68462-346-05) HDPE bottles of 1,000 tablets with continuous thread closures (NDC 68462-346-10) Cartons of 50 tablets (NDC 68462-346-11) containing 5 x 10 Unit-Dose Blisters (NDC 68462-346-40) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 152 words ▾

11 DESCRIPTION Levocetirizine dihydrochloride, USP the active component of Levocetirizine Dihydrochloride Tablets, USP is an orally active H 1 -receptor antagonist. The chemical name is (-)2-[2-[4-[(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride, USP is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties.

The empirical formula of levocetirizine dihydrochloride, USP is C 21 H 25 ClN 2 O 3 •2HCl. The molecular weight is 461.81 g/mol and the chemical structure is shown below: Levocetirizine dihydrochloride, USP is a white to off-white crystalline powder and soluble in methanol and in water. Levocetirizine Dihydrochloride Tablets, USP 5 mg are formulated as immediate release, white, oval, film-coated, biconvex tablets, one side embossed with ‘G’ break line ‘G’ and the other side plain for oral administration.

Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, macrogol 400, and titanium dioxide. structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Somnolence Caution patients against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride tablets. Concomitant Use of Alcohol and other Central Nervous System Depressants Instruct patients to avoid concurrent use of levocetirizine dihydrochloride tablets with alcohol or other central nervous system depressants because additional reduction in mental alertness may occur.

Dosing of Levocetirizine Dihydrochloride Tablets Do not exceed the recommended daily dose in adults and adolescents 12 years of age and older of 5 mg once daily in the evening. In children 6 to 11 years of age the recommended dose is 2.5 mg once daily in the evening. Advise patients to not ingest more than the recommended dose of levocetirizine dihydrochloride tablets because of the increased risk of somnolence at higher doses.

Risk of New Onset Pruritus After Discontinuation of Levocetirizine Dihydrochloride Tablets Inform patients pruritus has occurred within a few days of discontinuing levocetirizine dihydrochloride tablets among patients who used levocetirizine dihydrochloride tablets long term (e.g., few months to years). Pruritus may improve with restarting or tapering levocetirizine dihydrochloride tablets [see Warnings and Precautions ( 5.3 )] . Advise patients to seek medical advice if pruritus occurs.

Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com June 2026 logo

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Perennial Allergic Rhinitis Adults and Adolescents 12 Years of Age and Older The efficacy of levocetirizine dihydrochloride was evaluated in four randomized, placebo-controlled, double-blind clinical trials in adult and adolescent patients 12 years and older with symptoms of perennial allergic rhinitis. The four clinical trials include two dose-ranging trials of 4 weeks duration and two efficacy trials (one 6-week and one 6-month) in patients with perennial allergic rhinitis. These trials included a total of 1729 patients (752 males and 977 females) of whom 227 were adolescents 12 to 17 years of age.

Efficacy was assessed using a total symptom score from patient recording of 4 symptoms (sneezing, rhinorrhea, nasal pruritus, and ocular pruritus) in three studies and 5 symptoms (sneezing, rhinorrhea, nasal pruritus, ocular pruritus, and nasal congestion) in one study. Patients recorded symptoms using a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) once daily in the evening reflective of the 24 hour treatment period. The primary endpoint was the mean total symptom score averaged over the first week and over 4 weeks for perennial allergic rhinitis trials.

The two dose-ranging trials were conducted to evaluate the efficacy of levocetirizine dihydrochloride 2.5, 5, and 10 mg once daily in the evening. These trials were 4 weeks in duration and included patients with perennial allergic rhinitis. In these trials, each of the three doses of levocetirizine dihydrochloride demonstrated greater decrease in the reflective total symptom score than placebo and the difference was statistically significant for all three doses in the two studies.

Results for one of these trials are shown in Table 4. Table 4: Mean Reflective Total Symptom Score* in Allergic Rhinitis Dose-Ranging Trials Treatment N Baseline On Treatment Adjusted Mean Difference from Placebo Estimate 95% CI p-value Perennial Allergic Rhinitis Trial – Reflective total symptom score Levocetirizine dihydrochloride 2.5 mg 133 7.14 4.12 1.17 (0.71, 1.63) <0.001 Levocetirizine dihydrochloride 5 mg 127 7.18 4.07 1.22 (0.76, 1.69) <0.001 Levocetirizine dihydrochloride 10 mg 129 7.58 4.19 1.10 (0.64, 1.57) <0.001 Placebo 128 7.22 5.29 * Total symptom score is the sum of individual symptoms of sneezing, rhinorrhea, nasal pruritus, and ocular pruritus as assessed by patients on a 0 to 3 categorical severity scale.

One clinical trial evaluated the efficacy of levocetirizine dihydrochloride 5 mg once daily in the evening compared to placebo in patients with perennial allergic rhinitis over a 6-week treatment period. Another trial conducted over a 6-month treatment period assessed efficacy at 4 weeks. Levocetirizine dihydrochloride 5 mg demonstrated a greater decrease from baseline in the reflective total symptom score than placebo and the difference from placebo was statistically significant.

Results of the former are shown in Table 5. Table 5: Mean Reflective Total Symptom Score* in Allergic Rhinitis Trials Treatment N Baseline On Treatment Adjusted Mean Difference from Placebo Estimate 95% CI p-value Perennial Allergic Rhinitis Trial – Reflective total symptom score Levocetirizine dihydrochloride 5 mg 150 7.69 3.93 1.17 (0.70, 1.64) <0.001 Placebo 142 7.44 5.10 * Total symptom score is the sum of individual symptoms of sneezing, rhinorrhea, nasal pruritus, and ocular pruritus as assessed by patients on a 0 to 3 categorical severity scale.

Onset of action was evaluated in two environmental exposure unit studies in allergic rhinitis patients with a single dose of levocetirizine dihydrochloride 2.5 or 5 mg. Levocetirizine dihydrochloride 5 mg was found to have an onset of action 1 hour after oral intake. Onset of action was also assessed from the daily recording of symptoms in the evening before dosing in the allergic rhinitis trials.

In these trials, onset of effect was seen after 1 day of dosing. Pediatric Patients Less than 12 Year… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity studies have been performed with levocetirizine. However, evaluation of cetirizine carcinogenicity studies is relevant for determination of the carcinogenic potential of levocetirizine. In a 2-year carcinogenicity study, in rats, cetirizine was not carcinogenic at dietary doses up to 20 mg/kg (approximately 40, 40, 25, and 10 times the MRHDs in adults, children 6 to 11 years of age, children 2 to 5 years, and children 6 months to 2 years of age, respectively, on a mg/m 2 basis).

In a 2-year carcinogenicity study in mice, cetirizine caused an increased incidence of benign hepatic tumors in males at a dietary dose of 16 mg/kg (approximately 15, 15, 9, and 5 times the MRHDs in adults, children 6 to 11 years of age, children 2 to 5 years, and children 6 months to 2 years of age, respectively, on a mg/m 2 basis). No increased incidence of benign tumors was observed at a dietary dose of 4 mg/kg (approximately 4, 4, 2, and 1 times the MRHDs in adults, children 6 to 11 years of age, children 2 to 5 years, and children 6 months to 2 years of age, respectively on a mg/m 2 basis).

The clinical significance of these findings during long-term use of levocetirizine dihydrochloride is not known. Levocetirizine was not mutagenic in the Ames test, and not clastogenic in the human lymphocyte assay, the mouse lymphoma assay, and in vivo micronucleus test in mice. Fertility and reproductive performance were unaffected in male and female mice and rats that received cetirizine at oral doses up to 64 and 200 mg/kg/day, respectively (approximately 60 and 390 times the MRHD in adults on a mg/m 2 basis).

📄 Recent Major Changes 18 words ▾

Warnings and Precautions, Risk of New Onset Pruritus After Discontinuation Of Levocetirizine Dihydrochloride Tablets ( 5.3 ) 04/2025

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL label5mg90s

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
90 tablets68462-0346-90 155,871 Rx · $1,540,397
500 tablets this page68462-0346-05 No Medicaid data
Drug total (last 4 qtrs): 155,871 Rx · 5,951,655 units · $1,540,397 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Levocetirizine Dihydrochloride — the program that covers self-administered drugs. 11 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Levocetirizine Dihydrochloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$7.68M
Claims incl. refills
641.9K
Beneficiaries
464.6K
Spend / beneficiary
$16.53
Spend / claim
$11.97
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription 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 ✓ 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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Glenmark Pharmaceuticals Inc., USA. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 90 tablets (68462-0346-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Glenmark Pharmaceuticals Inc., USA 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.
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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.