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levocetirizine dihydrochloride 5 mg Tablet, Coated

by Dr. Reddy's Laboratories Inc. · 2 BOTTLE in 1 CARTON (43598-810-76) / 80 TABLET, COATED in 1 BOTTLE
NDC 43598-0810-76
🏷️ FDA NDC (as labeled) 43598-810-76 billing pads the product segment with a zero
This package
Contains80 tablet, coated in 1 bottle Pack sizes2 compare ↓
Also priced by: Part D plans $0.1730/unit — full pricing hub ↓
Also comes in: 80 tablets 43598-0810-80
OTC 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) 43598-810-76
Product NDC 43598-810
11-digit billing NDC 43598081076
RxCUI 855172
UNII SOD6A38AGA
Application # ANDA210375
SPL Set ID fb0a3619-9d5b-5c58-82f3-31f031672f33
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 2018-12-26
Route ORAL
Dosage form TABLET, COATED
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
Why two NDCs? The FDA registers this code as 43598-810-76 — 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 → 43598-0810-76. 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

LabelerDr. Reddy's Laboratories Inc.
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA210375 (ANDA)
Labeler code43598
First marketedDec 2018
Product typeHuman Otc Drug
Portfolio158 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

📗 Our plain-language guide HelloPharmacist
  • It's an antihistamine used to relieve the classic allergy symptoms — runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat — caused by seasonal hay fever o...
  • What exactly is levocetirizine used for?
  • It can, yes — drowsiness is the most commonly reported side effect and it's more likely at higher doses. Many people tolerate it fine, but until you know how it affects you, it's s...
  • Yes, you can take it with or without food — either way works. If you take it with a high-fat meal, it may take a little longer to kick in and the peak level in your blood may be sl...
📖 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.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1730 $27.68 / 160 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levocetirizine Dihydrochloride 5 mg 00093-7701-98 Teva 90 tablets $0.052 AB Availability likely —
Levocetirizine Dihydrochloride 5 mg 68462-0346-90 Glenmark 90 tablets $0.052 AB Availability likely —
Levocetirizine Dihydrochloride 5 mg 69367-0238-09 Westminster 90 tablets $0.052 AB Availability likely —
Allergy Relief 5 mg 46122-0531-05 AMERISOURCEBERGEN 35 tablets $0.220 — Availability likely —
24HR Allergy Relief 5 mg 70000-0362-01 LEADER/ 5 tablets $0.220 — 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 mgthis 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

🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 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.

📊 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 Marketing startStatus
43598-0810-76 You're viewing this 2 BOTTLE in 1 CARTON (43598-810-76) / 80 TABLET, COATED in 1 BOTTLE 2018-12-26 Active
43598-0810-80 1 BOTTLE in 1 CARTON (43598-810-80) / 80 TABLET, COATED in 1 BOTTLE 2018-12-26 Active

Pack size FAQ

What quantity is in NDC 43598-0810-76?
NDC 43598-0810-76 is listed by the FDA — 2 bottle in 1 carton / 80 tablet, coated in 1 bottle.
What NDC number is used to bill for this package of levocetirizine dihydrochloride 5 mg Tablet, Coated?
Bill NDC 43598-0810-76 — the 11-digit billing format is 43598081076. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 FDA registers it as 43598-810-76, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43598-0810-76, written without dashes as 43598081076. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 43598-0810-76, the first segment (43598) is the labeler code FDA assigned to Dr. Reddy's Laboratories Inc.; the middle segment (0810) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (76) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Dr. Reddy's Laboratories Inc.. 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 80 tablets (43598-0810-80). 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?
Dr. Reddy's Laboratories Inc. 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 25 words ▾

Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

⏱️ Dosage and Administration 99 words ▾

Directions adults 65 years of age and older ask a doctor adults and children 12-64 years of age take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours children under 6 years of age do not use consumers with kidney disease do not use

⚠️ Warnings 138 words ▾

Warnings Do not use if you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ever had trouble urinating or emptying your bladder When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask doctor if you have trouble urinating or emptying your bladder an allergic reaction to this product occurs.

Seek medical help right away. If pregnant or breast-feeding: if breast-feding: not recommended if pregnant: ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

🧪 Active Ingredient 10 words ▾

Active ingredient (in each tablet) Levocetirizine dihydrochloride USP, 5 mg

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43598-0809-18 · Dr. 43598-0811-05 · Dr. →
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.