by Sun Pharmaceutical Industries, Inc. · 30 TABLET, CHEWABLE in 1 BOTTLE
This is a package of 30 tablets of Cetirizine Hydrochloride 10 mg Tablet, Chewable from Sun Pharmaceutical Industries, Inc., no longer marketed (first marketed Sep 2011), no longer in the FDA NDC Directory; retail pharmacies pay about $2.22 per tablet (NADAC). It is the main listing for this product, which comes in 4 package sizes.
NDC 47335-0344-83
🏷️ FDA NDC (as labeled)47335-344-83billing pads the product segment with a zero
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy
⚠️
Other active recalls for Cetirizine Hydrochloride (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Jun 24, 2026 — Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. (JB Chemicals and Pharmaceuticals Ltd)· FDA recall D-0732-2026
Class III · Sep 12, 2025 — Tablet/Capsules Imprinted with Wrong ID (JB Chemicals and Pharmaceuticals Ltd)· FDA recall D-0032-2026
Class III · Sep 12, 2025 — Tablet/Capsules Imprinted with Wrong ID (JB Chemicals and Pharmaceuticals Ltd)· FDA recall D-0033-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Established class (EPC)Histamine-1 Receptor Antagonist
Mechanism of actionHistamine H1 Receptor Antagonists
DEA scheduleNon-controlled
Marketing categoryANDA
Marketing statusDiscontinued
FDA listing statusDiscontinued by firm (certified through Dec 2024)
Marketing start2011-09-09
RouteORAL
Dosage formTABLET, CHEWABLE
SubstanceCETIRIZINE HYDROCHLORIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-1441550020100520
GPI classCetirizine HCl
GCN Seq No053981
GCN21771
HICL code006544
Ingredient (HICL)Cetirizine Hcl
HIC1 codeZ
Therapeutic class — broad (HIC1)Body As A Whole
HIC2 codeZ2
Therapeutic class — intermediate (HIC2)Antihistamines, Antiserotonins, Immunosuppressants
HIC3 codeZ2Q
Therapeutic class — specific (HIC3)Antihistamines - 2Nd Generation
AHFS code04:08.00.00
AHFS classSecond Generation Antihistamines
FDB label nameCHILD CETIRIZINE 10 MG CHEW TB
FDB brand nameChildren's Cetirizine Hcl
Legend statusO — Over-the-counter (OTC) drug or device
Quick answers
GSN (GCN sequence number):053981
GCN:21771
GPI-14 (Medi-Span):41550020100520
HICL (First Databank):006544
AHFS class code:04:08.00.00
RxCUI (RxNorm):1014643
Why two NDCs?
The FDA registers this code as 47335-344-83 — 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 → 47335-0344-83. 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.
Drug family (ATC)Piperazine derivatives, Other antiallergics
How it worksHistamine 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.
Label name CHILD CETIRIZINE 10 MG CHEW TBIngredient Cetirizine Hcl
📖 What it is MedlinePlus · NLM
Cetirizine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Cetirizine is also used to treat urticaria (hives; itchy raised red bumps on skin). Cetirizine 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. Cetirizine is also available in combination with pseudoephedrine. This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read th...
It relieves allergy symptoms. Over-the-counter versions ease runny nose, sneezing, itchy, watery eyes and an itchy nose or throat from hay fever. Specific products treat hives, yea...
It can. Drowsiness was reported, and it was more common at higher doses in children. Be careful driving or using machinery until you know how it affects you, and avoid alcohol.
The oral solution can be taken with or without food. Food slightly delays how fast it works but does not change how much your body absorbs.
Check with me first if you take sedatives or tranquilizers, since they can add to drowsiness. The label found no significant interactions with azithromycin, pseudoephedrine, ketoco...
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.
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 system
Per ea
Per package
Retail pharmacies payNADAC · weekly
$2.219
$66.56 / 30 tablets
Medicaid paysCMS SDUD · 12 mo
$1.56
$46.82 / 30 tablets
Medicare drug plans payPart D · quarterly
No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
▲ Up 28% over the last 15 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.
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 this package?
This is a 30-count package — 30 tablet, chewable in 1 bottle.
How does this package differ from NDC 47335-0344-15?
Both are Cetirizine Hydrochloride 10 mg Tablet, Chewable — the drug itself is identical. This page's package is the 30-count one, while NDC 47335-0344-15 is the 30 tablets package.
What NDC number is used to bill for this package of Cetirizine Hydrochloride 10 mg Tablet, Chewable?
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.
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.
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
Inactive ingredients, 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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.
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.
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.
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.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat
⏱️Dosage and Administration161 words▾
Directions may be taken with or without water chew or crush tablets completely before swallowing For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) in 24 hours.
A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
⚠️Warnings1 words▾
Warnings
📦Storage and Handling30 words▾
Other information store between 20° to 25°C (68° to 77°F) do not use if inner safety seal is open or torn see top layer for lot number and expiration date
🧪Active Ingredient22 words▾
Active ingredient (in each chewable tablet) For 5 mg: Cetirizine hydrochloride, USP 5 mg For 10 mg: Cetirizine hydrochloride, USP 10 mg
🧪Inactive Ingredients51 words▾
Inactive ingredients acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor
🎯Purpose2 words▾
Purpose Antihistamine
📄Do Not Use25 words▾
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
📄Ask a Doctor Before Use If22 words▾
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
📄Ask a Doctor or Pharmacist Before Use If14 words▾
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
📄When Using This Product44 words▾
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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
📄Stop Use and Ask a Doctor If18 words▾
Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away.
🤰If Pregnant or Breast-Feeding16 words▾
If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use.
📄Keep Out of Reach of Children22 words▾
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)
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
Active ingredient: The part of a medicine that produces its intended effect on the body.
NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – 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
421
Units reimbursed last 4 qtrs
12.8K
Gross reimbursed last 4 qtrs
$19.9K
Avg / prescription
$47.35
Avg / unit
$1.5605
Latest quarter Q1 2026
46Rx
Medicaid pays / ea
$1.5605
gross reimbursed
vs
NADAC / ea
$2.2188
acquisition cost
=
Spread
−$0.6583
-30% 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 ⓘ
41% FFS59% MCO
Fee-for-service · 171 Rx Managed care · 250 Rx
State Medicaid map
Units reimbursed · per 100k residents
19.783.8
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1Maryland83.8 /100k
2Alabama24.6 /100k
3New York21.3 /100k
4Georgia19.7 /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.
Drug total (last 4 qtrs): 421 Rx · 12,774 units · $19,933 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
About this NDC listing & data coverage
Over-the-counter (OTC) productNo longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes)
✓ Available
Labeler
✓ Available
Product & package description
✓ Available
Marketing category & status
✓ Available
Active ingredient / dosage form / route
✓ Available
FDA label (SPL via DailyMed)
✓ Available
Package photos
— Not published for this NDCNo photo available yet for this listing.
Inactive ingredients (structured)
— Not published for this NDCThe labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)
✓ Available
Orange Book / therapeutic-equivalence data
— Not published for this NDCApplies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk
— Not published for this NDCMost self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)
✓ Available
“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
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (47335-0344-15), 100 tablets (47335-0344-88), 100 tablets (47335-0344-16). 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?
Sun Pharmaceutical Industries, 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.
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.
