Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Fexofenadine Hydrochloride 60 mg Tablet, 60-count — NDC 84324-045-01 (Billing 84324-0045-01)
by NUVICARE LLC · 60 TABLET in 1 BOTTLE
This is a package of 60 tablets of Fexofenadine Hydrochloride 60 mg Tablet from NUVICARE LLC, marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.
NDC 84324-0045-01
🏷️ FDA NDC (as labeled)
84324-045-01
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 84324-045-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 84324 labeler · 045 product · 01 package
- Package marketed since
- Jul 30, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0384324000602
- FDA record last changed
- Aug 20, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
84324-045-01
Product NDC
84324-045
11-digit billing NDC
84324004501
RxCUI
997501
UNII
2S068B75ZU
UPC
0384324000602
Application #
ANDA204507
SPL Set ID
dd0da52b-fc82-4ec9-854c-0d7c52e926fb
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
2026-07-30
Route
ORAL
Dosage form
TABLET
Substance
FEXOFENADINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 997501
Why two NDCs?
The FDA registers this code as 84324-045-01 — 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 → 84324-0045-01. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Pharmacologic class
Histamine-1 Receptor Antagonist
Drug family (ATC)
Other antihistamines for systemic use
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📖 What it is MedlinePlus · NLM
Fexofenadine is used to treat allergy symptoms: runny nose sneezing red, itchy, or watering eyes itching of the nose or throat It is also used to treat itching and redness caused by hives. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It relieves hay fever and other upper respiratory allergy symptoms like runny nose, sneezing, and itchy, watery eyes. Some products, like Allegra Hives 24hr, are for hives and the...
- No. The label says not to take it with fruit juices, so use water instead. Also avoid taking it at the same time as aluminum or magnesium antacids.
- Can I take fexofenadine with fruit juice?
- Yes, check with your doctor first. The label says your doctor should decide whether you need a different dose. The same goes for adults 65 and older.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Fexofenadine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 84324-0045-01 You're viewing this Main listing | 60 TABLET in 1 BOTTLE | 2026-07-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fexofenadine hydrochloride 60 mg 68001-0439-00 | BluePoint | 100 tablets | $0.153 | — | Availability likely | — |
| 12HR Allergy Relief 60 mg 70000-0586-01 | CARDINAL | 12 tablets | $0.153 | — | Availability likely | — |
| Allergy Relief 60 mg 83324-0009-12 | Chain | 12 tablets | $0.153 | — | Availability likely | — |
| Fexofenadine hydrochloride 60 mg 55111-0783-01 | Dr. | 100 tablets | $0.153 | — | Availability likely | — |
| Allergy Relief 60 mg 37808-0391-02 | HEB | 12 tablets | — | — | FDA listed | — |
| Allergy Relief 60 mg 72036-0191-03 | HARRIS | 288 tablets | — | — | FDA listed | — |
| Crcle Fexofenadine Hydrochloride 60 mg 57483-0230-01 | Innovus | 100 tablets | — | — | FDA listed | — |
| Fexofenadine Hydrochloride 60 mg 62207-0765-49 | Granules | 1000 tablets | — | — | FDA listed | — |
| Allegra Allergy 60 mg 41167-4131-02 | Chattem, | 12 tablets | — | — | FDA listed | — |
| Fexofenadine Hydrochloride 60 mg 62207-0889-49 | Granules | 1000 tablets | — | — | FDA listed | — |
| Allergy Relief 60 mg 73581-0103-10 | YYBA | 100 tablets | — | — | FDA listed | — |
| Allergy Relief 60 mg 69842-0492-02 | CVS | 12 tablets | — | — | FDA listed | — |
| Fexofenadine hydrochloride 60 mg 00363-0783-24 | Walgreens | 24 tablets | — | — | FDA listed | — |
| Fexofenadine Hydrochloride 60 mg 43598-0936-01 | Dr. | 100 tablets | — | — | FDA listed | — |
| Fexofenadine Hydrochloride 60 mg 73581-0025-01 | YYBA | 10 tablets | — | — | FDA listed | — |
| Gencare-Allergy Relief 60 mg 72090-0068-01 | Pioneer | 100 tablets | — | — | FDA listed | — |
| Fexofenadine Hydrochloride 60 mgthis 84324-0045-01 | NUVICARE | 60 tablets | — | — | FDA listed | — |
| Fexofenadine Hydrochloride 60 mg 58602-0877-09 | Aurohealth | 30 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
pink
ShapeOval
ImprintSG;201
Size12 mm
ScoringNot scored
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.
- FDA label on DailyMed · label index refreshed Oct 6, 2026
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.
🧪 Avoiding an ingredient? See Fexofenadine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
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 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 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 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 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 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
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.
11 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesanhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch, red iron oxide, stearic acid, titanium dioxide, yellow iron oxide.
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerNUVICARE LLC
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA204507 (ANDA)
Labeler code84324
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio43 products on file
More NDCs from NUVICARE LLC labeler code 84324
- Nuvicare Long-Acting Cough Relief Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled NDC 84324-037-01
- Ibuprofen 200 mg Tablet NDC 84324-038-01
- Ibuprofen 200 mg Tablet NDC 84324-039-01
- Allergy Relief fexofenadine hydrochloride 180 mg Tablet NDC 84324-040-01
- Nuvicare-Urinary Tract Defense methenamine, sodium salicylate 162 mg; 162.5 mg Tablet NDC 84324-041-01
- Nuvicare-Urinary Pain Relief Maximum Strength phenazopyridine hydrochloride 99.5 mg Tablet NDC 84324-042-01
- Pain Relief Acetaminophen 325 mg 325 mg Tablet NDC 84324-046-01
- Bisacodyl 5 mg Tablet, Coated NDC 84324-132-01
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 Ask a Doctor 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 ▾
Uses ■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ itchy, watery eyes ■ sneezing ■ itching of the nose or throat
⏱️ Dosage and Administration ▾
Directions Adults and children 12 years of age and over Take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours Children under 12 years of age Do not use Adults 65 years of age and older Ask a doctor Consumers with kidney disease Ask a doctor
⚠️ Warnings ▾
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Fexofenadine HCl 60 mg
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch, red iron oxide, stearic acid, titanium dioxide, yellow iron oxide.
🎯 Purpose ▾
Purpose Antihistamine
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
📄 When Using This Product ▾
When using this product ■ do not take more than directed ■ do not take at the same time as aluminum or magnesium antacids ■ do not take with fruit juices (see Directions)
📄 Stop Use and Ask a Doctor If ▾
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 pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
📄 Other Information ▾
Other Information ■ Store between 20°to 25°C (68°to 77°F) ■ Protect from excessive moisture
📄 Questions or Comments ▾
Questions or comments? Call +1 (718) 337-8733 or email: [email protected]
📄 Package Label / Principal Display Panel ▾
NDC 84324-045-01 L186-00 NC-Allergy Relief-84324-045-01
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fexofenadine hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 31%
Female · 69%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
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 | ✓ Available |
| Inactive ingredients (structured) | ✓ 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 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.
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 NUVICARE LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NUVICARE LLC 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.