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Cetirizine Hydrochloride 5 mg Tablet, 100-count — NDC 49483-682-01 (Billing 49483-0682-01)

by TIME CAP LABORATORIES, INC. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Cetirizine Hydrochloride 5 mg Tablet from TIME CAP LABORATORIES, INC., marketed since May 2022 and currently FDA-listed; retail pharmacies pay about $0.0476 per tablet (NADAC). It is this product's only package size.

NDC 49483-0682-01
🏷️ FDA NDC (as labeled) 49483-682-01 billing pads the product 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) 49483-682-01
Product NDC 49483-682
11-digit billing NDC 49483068201
NCPDP billing unit EA — each (per item)
RxCUI 1014676
UNII 64O047KTOA
UPC 0349483682014
Application # ANDA078933
SPL Set ID dfbddafb-9455-5805-e053-2a95a90ad0d9
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 2022-05-30
Route ORAL
Dosage form TABLET
Substance CETIRIZINE HYDROCHLORIDE

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

GPI-14 41550020100310
GPI class Allergy Relief Cetirizine
GCN Seq No 024484
GCN 49292
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 ALLERGY RLF (CETRZN) 5 MG TAB
FDB brand name Allergy Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 024484
  • GCN: 49292
  • GPI-14 (Medi-Span): 41550020100310
  • HICL (First Databank): 006544
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 1014676
Why two NDCs? The FDA registers this code as 49483-682-01 — 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 → 49483-0682-01. 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 ALLERGY RLF (CETRZN) 5 MG TAB Ingredient 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...

Read the full MedlinePlus article ↗
📗 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 $0.048 $4.76 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2961 $29.61 / 100 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
Sep 2022 Feb 2024 Apr 2026 Sep 2026 $0.056 $0.048
▼ Down 3% over the last 16 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
49483-0682-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2022-05-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetirizine Hydrochloride 5 mg 00378-3635-01 Mylan 100 tablets $0.048 — Availability likely —
Cetirizine Hydrochloride 5 mg 16571-0401-10 Rising 100 tablets $0.048 — Availability likely —
Cetirizine Hydrochloride 5 mgthis 49483-0682-01 TIME 100 tablets $0.048 — Availability likely —
Cetirizine Hydrochloride Tablets, 5 mg 25000-0219-03 MARKSANS 30 tablets — — FDA listed —
Zyrtec Allergy 5 mg 50580-0754-15 Kenvue 1 tablet — — FDA listed —
Cetirizine Hydrochloride (Allergy) 5 mg 58602-0444-09 Aurohealth 30 tablets — — FDA listed —
Cetirizine Hydrochloride (Hives Relief) 5 mg 58602-0446-09 Aurohealth 30 tablets — — FDA listed —
Cetirizine Hydrochloride 5 mg 63629-4914-01 Bryant 30 tablets — — FDA listed —
Cetirizine Hydrochloride 5 mg 65162-0045-03 Amneal 30 tablets — — FDA listed —
Cetirizine Hydrochloride Hives Relief 5 mg 65162-0145-03 Amneal 30 tablets — — FDA listed —
Cetirizine Hydrochloride 5 mg 71205-0093-15 Proficient 15 tablets — — FDA listed —
Cetirizine HCl 5 mg 72657-0128-03 GLENMARK 300 tablets — — FDA listed —
Cetirizine HCl 72657-0130-05 GLENMARK 90 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

The official label also statesInactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

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

LabelerTIME CAP LABORATORIES, INC.
Application holderMARKSANS PHARMA LTD
FDA applicationANDA078933 (ANDA)
Labeler code49483
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio25 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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 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 67 words ▾

Directions adults and children 6 years and over 1 or 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

⚠️ Warnings 152 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 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 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 9 words ▾

Active ingredient (in each tablet) Cetirizine HCl 5 mg

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 25 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 If 22 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 If 14 words ▾

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

📄 When Using This Product 31 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

📄 Stop Use and Ask a Doctor If 19 words ▾

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

🤰 If Pregnant or Breast-Feeding 18 words ▾

If pregnant or breast-feeding: • if breast-feeding: Not recommended • if pregnant: Ask a health professional before use

📄 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).

📄 Other Information 11 words ▾

Other information • store between 20° to 25°C (68° to 77°F).

📄 Questions or Comments 5 words ▾

Questions or comments? Call 1-877-290-4008

📄 Package Label / Principal Display Panel 1 words ▾

682R-timely-cetirizine10mg-100ct-label

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
11.7K
Units reimbursed last 4 qtrs
360.5K
Gross reimbursed last 4 qtrs
$106.7K
Avg / prescription
$9.14
Avg / unit
$0.2961
Latest quarter Q1 2026
3KRx
Medicaid pays / ea
$0.2961
gross reimbursed
vs
NADAC / ea
$0.0476
acquisition cost
=
Spread
+$0.2485
+522% 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 ⓘ
42% FFS 58% MCO
Fee-for-service · 4,950 Rx Managed care · 6,730 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 17,096 units · 219 per 100k residents WA Idaho: no data reported ID Montana: 1,199 units · 106 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 10,610 units · 180 per 100k residents WI Michigan: 13,086 units · 130 per 100k residents MI New York: 30,231 units · 154 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 16,315 units · 385 per 100k residents OR Nevada: 1,331 units · 41.7 per 100k residents NV Wyoming: no data reported WY South Dakota: 6,939 units · 755 per 100k residents SD Iowa: 18,746 units · 585 per 100k residents IA Illinois: 8,155 units · 65.0 per 100k residents IL Indiana: 1,940 units · 28.3 per 100k residents IN Ohio: 27,715 units · 235 per 100k residents OH Pennsylvania: 18,859 units · 146 per 100k residents PA New Jersey: 6,938 units · 74.7 per 100k residents NJ Massachusetts: 1,444 units · 20.6 per 100k residents MA California: 24,409 units · 62.6 per 100k residents CA Utah: 330 units · 9.7 per 100k residents UT Colorado: 2,309 units · 39.3 per 100k residents CO Nebraska: 15,218 units · 769 per 100k residents NE Missouri: 9,068 units · 146 per 100k residents MO Kentucky: 30,664 units · 678 per 100k residents KY West Virginia: 2,776 units · 157 per 100k residents WV Virginia: 4,507 units · 51.7 per 100k residents VA Maryland: 2,527 units · 40.9 per 100k residents MD Connecticut: 2,381 units · 65.8 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,499 units · 20.2 per 100k residents AZ New Mexico: 364 units · 17.2 per 100k residents NM Kansas: 11,110 units · 378 per 100k residents KS Arkansas: no data reported AR Tennessee: 1,398 units · 19.6 per 100k residents TN North Carolina: 23,672 units · 218 per 100k residents NC South Carolina: 7,639 units · 142 per 100k residents SC Delaware: no data reported DE Oklahoma: 3,750 units · 92.5 per 100k residents OK Louisiana: 915 units · 20.0 per 100k residents LA Mississippi: 4,832 units · 164 per 100k residents MS Alabama: 10,683 units · 209 per 100k residents AL Georgia: 15,731 units · 143 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 4,110 units · 18.2 per 100k residents FL
Units reimbursed · per 100k residents
9.7769
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 Nebraska 769 /100k
2 South Dakota 755 /100k
3 Kentucky 678 /100k
4 Iowa 585 /100k
5 Oregon 385 /100k
6 Kansas 378 /100k
7 Ohio 235 /100k
8 Washington 219 /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.
← 49483-0673-73 · TIME 49483-0686-07 · TIME →
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.