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Levocetirizine Dihydrochloride 5 mg Tablet, Film Coated, 90-count — NDC 42571-0122-90 package photo

Levocetirizine Dihydrochloride 5 mg Tablet, Film Coated, 90-count

by Micro Labs Limited · 90 TABLET, FILM COATED in 1 BOTTLE (42571-122-90)
NDC 42571-0122-90
🏷️ FDA NDC (as labeled) 42571-122-90 billing pads the product segment with a zero
This package
Contains90-count Cost per ea$0.0511 NADAC Per package$4.60 / 90 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.2943/unit · Part D plans $0.1730/unit — full pricing hub ↓
Also comes in: 10 tablets 42571-0122-32 30 tablets 42571-0122-30 500 tablets 42571-0122-05
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 42571-122-90
Product NDC 42571-122
11-digit billing NDC 42571012290
NCPDP billing unit EA — each (per item)
RxCUI 855172
UNII SOD6A38AGA
UPC 0342571122904
Application # ANDA202046
SPL Set ID 717eb542-3a05-485e-be76-3930efb40d33
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 2013-09-30
Route ORAL
Dosage form TABLET, FILM COATED
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
GPI-14 41550027100320
GPI class Levocetirizine Dihydrochloride
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 42571-122-90 — 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 → 42571-0122-90. 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.

🏭 Manufacturer & labeler

LabelerMicro Labs Limited
Application holderMICRO LABS LTD INDIA
FDA applicationANDA202046 (ANDA)
Labeler code42571
First marketedSep 2013
Product typeHuman Prescription Drug
Portfolio190 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LEVOCETIRIZINE 5 MG TABLET Ingredient Levocetirizine Dihydrochloride
📖 What it is MedlinePlus · NLM

Levocetirizine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes It is also used to treat symptoms of urticaria (hives). Levocetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
📗 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.

💊 What it looks like

Color white
ShapeOval
ImprintI12
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 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 R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in 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 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.

💲 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 $0.051 $4.60 / 90 tablets
Medicaid paysCMS SDUD · 12 mo $0.2943 $26.49 / 90 tablets
Medicare drug plans payPart D · Q2 2026 $0.1730 $15.57 / 90 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.085 $0.051
▼ Down 33% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levocetirizine Dihydrochloride 5 mg 00093-7701-98 Teva 90 tablets $0.051 AB Availability likely —
Levocetirizine Dihydrochloride 5 mgthis 42571-0122-90 Micro 90 tablets $0.051 AB Availability likely —
Levocetirizine Dihydrochloride 5 mg 68462-0346-90 Glenmark 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 +327%
24HR Allergy Relief 5 mg 70000-0362-01 LEADER/ 5 tablets $0.218 — Availability likely +327%
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 42571-0312-11 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 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

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

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 42571-0122-90, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
163.4K
Units reimbursed last 4 qtrs
5.7M
Gross reimbursed last 4 qtrs
$1.68M
Avg / prescription
$10.26
Avg / unit
$0.2943
Latest quarter Q1 2026
34.6KRx
Medicaid pays / ea
$0.2943
gross reimbursed
vs
NADAC / ea
$0.0511
acquisition cost
=
Spread
+$0.2432
+476% 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 ⓘ
31% FFS 69% MCO
Fee-for-service · 50,500 Rx Managed care · 112,867 Rx
State Medicaid map
Alaska: 4,051 units · 553 per 100k residents AK Maine: no data reported ME Washington: 3,215 units · 41.2 per 100k residents WA Idaho: 10,120 units · 515 per 100k residents ID Montana: 6,249 units · 552 per 100k residents MT North Dakota: no data reported ND Minnesota: 109,357 units · 1,906 per 100k residents MN Wisconsin: 85,737 units · 1,451 per 100k residents WI Michigan: 232,791 units · 2,319 per 100k residents MI New York: 421,017 units · 2,151 per 100k residents NY Vermont: 1,590 units · 246 per 100k residents VT New Hampshire: no data reported NH Oregon: 5,395 units · 127 per 100k residents OR Nevada: 15,824 units · 495 per 100k residents NV Wyoming: 277 units · 47.4 per 100k residents WY South Dakota: 4,526 units · 492 per 100k residents SD Iowa: 10,943 units · 341 per 100k residents IA Illinois: 161,314 units · 1,285 per 100k residents IL Indiana: 113,207 units · 1,650 per 100k residents IN Ohio: 128,910 units · 1,094 per 100k residents OH Pennsylvania: 194,863 units · 1,503 per 100k residents PA New Jersey: 276,052 units · 2,971 per 100k residents NJ Massachusetts: 56,680 units · 810 per 100k residents MA California: 186,586 units · 479 per 100k residents CA Utah: 2,587 units · 75.7 per 100k residents UT Colorado: 44,452 units · 756 per 100k residents CO Nebraska: 29,692 units · 1,501 per 100k residents NE Missouri: 127,868 units · 2,064 per 100k residents MO Kentucky: 998,693 units · 22,066 per 100k residents KY West Virginia: 77,366 units · 4,371 per 100k residents WV Virginia: 146,575 units · 1,682 per 100k residents VA Maryland: 62,616 units · 1,013 per 100k residents MD Connecticut: 296,353 units · 8,193 per 100k residents CT Rhode Island: 19,094 units · 1,744 per 100k residents RI Arizona: 43,229 units · 582 per 100k residents AZ New Mexico: 49,257 units · 2,330 per 100k residents NM Kansas: 24,170 units · 822 per 100k residents KS Arkansas: 1,545 units · 50.4 per 100k residents AR Tennessee: 214,043 units · 3,004 per 100k residents TN North Carolina: 533,335 units · 4,922 per 100k residents NC South Carolina: 58,473 units · 1,088 per 100k residents SC Delaware: 16,931 units · 1,642 per 100k residents DE Oklahoma: 7,858 units · 194 per 100k residents OK Louisiana: 458,606 units · 10,026 per 100k residents LA Mississippi: no data reported MS Alabama: 144,040 units · 2,820 per 100k residents AL Georgia: 157,402 units · 1,427 per 100k residents GA D.C.: 6,575 units · 968 per 100k residents DC Hawaii: no data reported HI Texas: 44,363 units · 145 per 100k residents TX Florida: 104,283 units · 461 per 100k residents FL
Units reimbursed · per 100k residents
41.222,066
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 Kentucky 22,066 /100k
2 Louisiana 10,026 /100k
3 Connecticut 8,193 /100k
4 North Carolina 4,922 /100k
5 West Virginia 4,371 /100k
6 Tennessee 3,004 /100k
7 New Jersey 2,971 /100k
8 Alabama 2,820 /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.

💊 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 tablets this page42571-0122-90 163,367 Rx · $1,676,824
500 tablets42571-0122-05 No Medicaid data
30 tablets42571-0122-30 No Medicaid data
10 tablets42571-0122-32 No Medicaid data
Drug total (last 4 qtrs): 163,367 Rx · 5,698,109 units · $1,676,824 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
42571-0122-05 500 TABLET, FILM COATED in 1 BOTTLE (42571-122-05) — — 2013-09-30 Active
42571-0122-30 30 TABLET, FILM COATED in 1 BOTTLE (42571-122-30) — — 2013-09-30 Active
42571-0122-32 10 BLISTER PACK in 1 CARTON (42571-122-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-122-11) — — 2013-09-30 Active
42571-0122-90 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE (42571-122-90) $0.0511 / ea $4.60 2013-09-30 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 42571-0122-90?
NDC 42571-0122-90 is a 90-count package — 90 tablet, film coated in 1 bottle.
What is the difference between NDC 42571-0122-90 and NDC 42571-0122-30?
Both are Levocetirizine Dihydrochloride 5 mg Tablet, Film Coated — the drug itself is identical. NDC 42571-0122-90 is the 90-count package, while NDC 42571-0122-30 is the 30 tablets package.
What NDC number is used to bill for this package of Levocetirizine Dihydrochloride 5 mg Tablet, Film Coated?
Bill NDC 42571-0122-90 — the 11-digit billing format is 42571012290. 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.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 99 words ▾

1 INDICATIONS AND USAGE Levocetirizine dihydrochloride is 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 years of age and older.

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 years of age and older.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Levocetirizine dihydrochloride is 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 tablet 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 tablet 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 51 words ▾

3 DOSAGE FORMS AND STRENGTHS Levocetirizine dihydrochloride tablets, USP are white to off white, oval shaped biconvex film coated tablet debossed with ‘I’ and ‘12’ on one side and score line on the other side and contain 5 mg levocetirizine dihydrochloride. Immediate release breakable (scored) tablets, 5 mg ( 3 )

⛔ Contraindications 140 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 Somnolence: Somnolence, fatigue, and asthenia have been reported with use of levocetirizine dihydrochloride in some patients in clinical trials. 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 ) Urinary Retention: Urinary retention has been reported with use of levocetirizine dihydrochloride. 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 post marketing 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 Cases of pruritus after discontinuation of levocetirizine dihydrochloride have been reported in the postmarketing setting in patients where pruritus was not present before initiation of levocetirizine dihydrochloride. Pruritus occurred within a few days of discontinuing levocetirizine dihydrochloride among patients who used levocetirizine dihydrochloride 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, symptoms may improve with restarting or tapering levocetirizine dihydrochloride.

🤒 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 Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience 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 trials of another drug and may not reflect the rates observed in practice. 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 leadi…

🔄 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 doses of 2.5 mg and 1.25 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 developmen…

🤰 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) ] .

🧓 Geriatric Use 89 words ▾

8.5Geriatric Use Clinical studies of levocetirizine dihydrochloride for each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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.

🆘 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…

🧬 Mechanism of Action 79 words ▾

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.

📦 How Supplied / Storage and Handling 96 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Levocetirizine dihydrochloride tablets, USP are white to off white, oval shaped biconvex, film-coated tablet debossed with 'I' and '12' on one side and score line on the other side and contain 5 mg levocetirizine dihydrochloride. They are supplied in 1) Bottles of 30's tablets NDC 42571-122-30 2) Bottles of 90's tablets NDC 42571-122-90 3) Bottles of 500's tablets NDC 42571-122-05 4) Carton of 10x10 Unit-dose Tablets NDC 42571-122-32 Storage: Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86°F) [see USP Controlled Room Temperature].

📋 Description 156 words ▾

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

The molecular formula of levocetirizine dihydrochloride is C 21 H 25 ClN 2 O 3 •2HCl. The molecular weight is 461.82 and the chemical structure is shown below: Levocetirizine dihydrochloride is a white to off white powder and is freely soluble in water and in methanol. Levocetirizine dihydrochloride tablets USP, 5 mg are formulated as immediate release, white to off white, oval shaped biconvex, film-coated tablet for oral administration.

The tablets are debossed with 'I' and '12' on one side and score line on the other side. Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol. levo-strct.jpg

💬 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 [see Warnings and Precautions (5.1) ] . Concomitant Use of Alcohol and other Central Nervous System Depressants Instruct patients to avoid concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants because additional reduction in mental alertness may occur [see Warnings and Precautions (5.1) ] .

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

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 because of the increased risk of somnolence at higher doses.

The brands listed are trademarks of their respective owners and are not trademarks of Micro Labs Ltd. The makers of these brands are not affiliated with and do not endorse Micro Labs Ltd., or its products. Manufactured by: Micro Labs Limited Goa-403 722, INDIA.

Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev. 08/2025

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