Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Fexofenadine hydrochloride 30 mg Tablet, 100-count — NDC 55111-782-01 (Billing 55111-0782-01)
by Dr. Reddy's Laboratories Limited · 100 TABLET in 1 BOTTLE
This is a package of 100 tablets of Fexofenadine hydrochloride 30 mg Tablet from Dr. Reddy's Laboratories Limited, marketed since Jan 2011 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.
NDC 55111-0782-01
🏷️ FDA NDC (as labeled)
55111-782-01
billing pads the product segment with a zero
This package
Contains100-count
Pack sizes4 compare ↓
Main listing for product 55111-782 · Also comes in:
30 tablets 55111-782-30
90 tablets 55111-782-90
100 tablets 55111-782-78
🗂️ FDA directory synced Oct 8, 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 →
NDC database record
One package, one record: these facts belong to NDC 55111-782-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 55111 labeler · 782 product · 01 package
- Package marketed since
- Jan 3, 2011
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5511178201 8
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
55111-782-01
Product NDC
55111-782
11-digit billing NDC
55111078201
UNII
2S068B75ZU
Application #
ANDA076502
SPL Set ID
864e3052-5787-bf11-9d17-11274ca2304f
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
2011-01-03
Route
ORAL
Dosage form
TABLET
Substance
FEXOFENADINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 997420
Why two NDCs?
The FDA registers this code as 55111-782-01 — 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 → 55111-0782-01. 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 8, 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 |
|---|---|---|---|---|
| 55111-0782-01 You're viewing this Main listing | 100 TABLET in 1 BOTTLE | 2011-01-03 | — | Active |
| 55111-0782-30 55111-782-30 | 30 TABLET in 1 BOTTLE | 2011-01-03 | — | Active |
| 55111-0782-78 55111-782-78 | 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK | 2011-01-03 | — | Active |
| 55111-0782-90 55111-782-90 | 90 TABLET in 1 BOTTLE | 2011-01-03 | — | Active |
Pack size FAQ
What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 55111-0782-30?
Both are Fexofenadine hydrochloride 30 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 55111-0782-30 is the 30 tablets package.
What NDC number is used to bill for this package of Fexofenadine hydrochloride 30 mg Tablet?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fexofenadine hydrochloride 30 mgthis 55111-0782-01 | Dr. | 100 tablets | — | — | FDA listed | — |
| Childrens Allergy Relief 30 mg 63548-0662-05 | PLD | 500 tablets | — | — | FDA listed | — |
| Fexofenadine Hydrochloride 30 mg 58602-0876-09 | 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
🏛️
2011
On the market since
Jan 2011
📍
2026
Currently FDA-listed
15 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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
Pink
ShapeOval
Imprint194;R
Size7 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 8, 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 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 WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
-
UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
-
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 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII SMD1X3XO9M
Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
-
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 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 statescolloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and 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.- FDA label on DailyMed · label index refreshed Oct 8, 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
LabelerDr. Reddy's Laboratories Limited
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA076502 (ANDA)
Labeler code55111
First marketedJan 2011
Product typeHuman Otc Drug
Portfolio200 products on file
More NDCs from Dr. Reddy's Laboratories Limited labeler code 55111
- Valsartan 40 mg Tablet, Film Coated NDC 55111-731-01
- Valsartan 80 mg Tablet, Film Coated NDC 55111-732-01
- Valsartan 160 mg Tablet, Film Coated NDC 55111-733-01
- Valsartan 320 mg Tablet, Film Coated NDC 55111-734-01
- Lansoprazole 15 mg Capsule, Delayed Release NDC 55111-739-27
- Valganciclovir 450 mg Tablet, Film Coated NDC 55111-762-05
- Fexofenadine hydrochloride 60 mg Tablet NDC 55111-783-01
- Fexofenadine hydrochloride 180 mg Tablet NDC 55111-784-01
- Sevelamer Carbonate 800 mg Tablet, Film Coated NDC 55111-789-11
- Febuxostat 40 mg Tablet NDC 55111-796-01
- Febuxostat 80 mg Tablet NDC 55111-797-01
- Guaifenesin and Pseudoephedrine HCL 600 mg; 60 mg Tablet, Extended Release NDC 55111-798-09
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
📄 Do Not Use
📄 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
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use(s) 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 30 mg adults and children 12 yearsof age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 6 years of age do not use Adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor 60 mg: adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take morethan 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 180 mg: adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than1 tablet 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. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
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 doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, 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.
🧪 Active Ingredient ▾
Active ingredient(s) Fexofenadine HCl USP, 30 mg Fexofenadine HCl USP, 60 mg Fexofenadine HCl USP, 180 mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide
🎯 Purpose ▾
Purpose Antihistamine
📄 Do Not Use ▾
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
📄 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 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 right away.
📄 Questions or Comments ▾
Questions? Call 1-888-375-3784
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION 180 mg Container:
30 mg Carton:
60 mg Carton:
60 mg Container:
180 mg Carton Label:
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 Dr. Reddy's Laboratories Limited. 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 3 other package presentations of this same product, including 30 tablets (55111-0782-30), 90 tablets (55111-0782-90), 100 tablets (55111-0782-78). 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 Limited 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.