Home › NDC Lookup › Ingredients › Cetirizine Hydrochloride › 00781-5283-64
Cetirizine Hydrochloride 5 mg Tablet, Chewable — NDC 00781-5283-64 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cetirizine Hydrochloride 5 mg Tablet, Chewable — NDC 0781-5283-64 (Billing 00781-5283-64)

by Sandoz Inc · 30 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK

This is a package of Cetirizine Hydrochloride 5 mg Tablet, Chewable from Sandoz Inc, marketed since Feb 2008 and currently FDA-listed; retail pharmacies pay about $1.99 per unit (NADAC). It is this product's only package size.

NDC 00781-5283-64
🏷️ FDA NDC (as labeled) 0781-5283-64 billing pads the labeler segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for 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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0781-5283-64
Product NDC 0781-5283
11-digit billing NDC 00781528364
NCPDP billing unit EA — each (per item)
RxCUI 1014643
UNII 64O047KTOA
Application # ANDA078692
SPL Set ID 817d07cf-5e31-421f-9e95-943bae01f5b0
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 2008-02-14
Route ORAL
Dosage form TABLET, CHEWABLE
Substance CETIRIZINE HYDROCHLORIDE

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

GPI-14 41550020100510
GPI class Cetirizine HCl
GCN Seq No 053980
GCN 21769
HICL code 006544
Ingredient (HICL) Cetirizine Hcl
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 CETIRIZINE HCL 5 MG CHEW TAB
FDB brand name Cetirizine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 053980
  • GCN: 21769
  • GPI-14 (Medi-Span): 41550020100510
  • HICL (First Databank): 006544
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 1014643
Why two NDCs? The FDA registers this code as 0781-5283-64 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00781-5283-64. 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, Other antiallergics
How it works Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CETIRIZINE HCL 5 MG CHEW TAB Ingredient Cetirizine Hcl
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Cetirizine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Cetirizine Hydrochloride — tap one for details:

BeerModerate WineModerate Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Cetirizine Hydrochloride (5 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $1.992 $59.76 / 30 tablet
Medicaid paysCMS SDUD · 12 mo $2.26 $67.86 / 30 tablet
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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $2.567 $1.811
▼ Down 5% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00781-5283-64 You're viewing this Main listing 30 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK 2008-02-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetirizine Hydrochloride 5 mgthis 00781-5283-64 Sandoz 1 tablet $1.992 — Availability likely —
Cetirizine Hydrochloride 5 mg 47335-0343-83 Sun 30 tablets $2.324 — Discontinued +17%
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

🏛️
2008
On the market since
Feb 2008
📍
2026
Currently FDA-listed
18 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII JV039JZZ3A
    Betadex is a modified sugar molecule derived from starch. It acts as a solubilizer and stabilizer in medicines, helping dissolve poorly soluble drugs and keep them stable during storage.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

13 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesacesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor. Questions? 1-800-525-8747 Manufactured by Sandoz Private Limited, India for Sandoz Inc., Princeton, NJ 08540 Product of India Revised: 04/2026

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationANDA078692 (ANDA)
Labeler code00781
First marketedFeb 2008
Product typeHuman Otc Drug
Portfolio391 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.

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

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

⏱️ Dosage and Administration 95 words ▾

Directions • may be taken with or without water • chew or crush tablets completely before swallowing adults and children 6 years and over 1 to 2 tablets once daily; depending upon severity of symptoms; do not take more than 2 tablets in 24 hours adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information Store between 20ºC to 25º C (68ºF to 77º F)

⚠️ Warnings 148 words ▾

Warnings 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 if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. 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 if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use.

🧪 Active Ingredient 10 words ▾

Active ingredient (in each chewable tablet) Cetirizine HCl 5 mg

🧪 Inactive Ingredients 52 words ▾

Inactive ingredients acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor. Questions? 1-800-525-8747 Manufactured by Sandoz Private Limited, India for Sandoz Inc., Princeton, NJ 08540 Product of India Revised: 04/2026

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Keep Out of Reach of Children 22 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).

📄 Package Label / Principal Display Panel 74 words ▾

Principal Display Panel NDC 0781-5283-64 Children's Cetirizine HCl Chewable Tablets 5 mg antihistamine Tutti Frutti Flavored 30 Chewable Tablets Do not use if individual blister unit is open or torn ALLERGY Indoor & Outdoor Allergies 6 years and older 5 mg each 24 hour Relief of • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose • Actual Size No water needed Chew or crush tablets completely before swallowing cetirizine5mg

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
37.7K
Units reimbursed last 4 qtrs
1.2M
Gross reimbursed last 4 qtrs
$2.71M
Avg / prescription
$71.77
Avg / unit
$2.2619
Latest quarter Q1 2026
7KRx
Medicaid pays / ea
$2.2619
gross reimbursed
vs
NADAC / ea
$1.9921
acquisition cost
=
Spread
+$0.2698
+14% 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 ⓘ
46% FFS 54% MCO
Fee-for-service · 17,195 Rx Managed care · 20,511 Rx
State Medicaid map
Alaska: 3,868 units · 528 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: 2,403 units · 122 per 100k residents ID Montana: no data reported MT North Dakota: 4,669 units · 596 per 100k residents ND Minnesota: 7,796 units · 136 per 100k residents MN Wisconsin: no data reported WI Michigan: 18,065 units · 180 per 100k residents MI New York: 86,405 units · 441 per 100k residents NY Vermont: no data reported VT New Hampshire: 17,529 units · 1,250 per 100k residents NH Oregon: 7,083 units · 167 per 100k residents OR Nevada: 14,927 units · 467 per 100k residents NV Wyoming: 5,313 units · 910 per 100k residents WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 81,935 units · 653 per 100k residents IL Indiana: 25,367 units · 370 per 100k residents IN Ohio: 21,239 units · 180 per 100k residents OH Pennsylvania: 5,991 units · 46.2 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 1,088 units · 15.5 per 100k residents MA California: 65,114 units · 167 per 100k residents CA Utah: 930 units · 27.2 per 100k residents UT Colorado: 495 units · 8.4 per 100k residents CO Nebraska: 330 units · 16.7 per 100k residents NE Missouri: 4,139 units · 66.8 per 100k residents MO Kentucky: no data reported KY West Virginia: 127,026 units · 7,177 per 100k residents WV Virginia: 7,009 units · 80.4 per 100k residents VA Maryland: 75,651 units · 1,224 per 100k residents MD Connecticut: 7,752 units · 214 per 100k residents CT Rhode Island: 1,984 units · 181 per 100k residents RI Arizona: 131,309 units · 1,767 per 100k residents AZ New Mexico: 51,190 units · 2,421 per 100k residents NM Kansas: 2,778 units · 94.5 per 100k residents KS Arkansas: no data reported AR Tennessee: 7,035 units · 98.7 per 100k residents TN North Carolina: 22,707 units · 210 per 100k residents NC South Carolina: 58,783 units · 1,094 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 10,447 units · 228 per 100k residents LA Mississippi: no data reported MS Alabama: 205,810 units · 4,029 per 100k residents AL Georgia: 82,517 units · 748 per 100k residents GA D.C.: 1,261 units · 186 per 100k residents DC Hawaii: 27,461 units · 1,914 per 100k residents HI Texas: no data reported TX Florida: 958 units · 4.2 per 100k residents FL
Units reimbursed · per 100k residents
4.27,177
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 West Virginia 7,177 /100k
2 Alabama 4,029 /100k
3 New Mexico 2,421 /100k
4 Hawaii 1,914 /100k
5 Arizona 1,767 /100k
6 New Hampshire 1,250 /100k
7 Maryland 1,224 /100k
8 South Carolina 1,094 /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.
← 00781-5224-01 · Sandoz 00781-5284-64 · Sandoz →
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.