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Fexofenadine HCl and Pseudoephedrine 180 mg; 240 mg Tablet, Extended Release, 5-count

by Dr.Reddy's Laboratories Inc · 1 BLISTER PACK in 1 CARTON (43598-892-07) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
NDC 43598-0892-07
🏷️ FDA NDC (as labeled) 43598-892-07 billing pads the product segment with a zero
This package
Contains5-count Pack sizes4 compare ↓
Also comes in: 5 tablets 43598-0892-29 5 tablets 43598-0892-35 50000 tablets 43598-0892-00
Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Aug 27, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 43598-892-07
Product NDC 43598-892
11-digit billing NDC 43598089207
SPL Set ID d4e66d84-5ce8-36a1-7a99-2a2a0f38ce19
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2022-05-17
Marketing end 2026-08-31
Dosage form TABLET, EXTENDED RELEASE
Substance FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 43598-892-07 — 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 → 43598-0892-07. 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.

🏭 Manufacturer & labeler

LabelerDr.Reddy's Laboratories Inc
Labeler code43598
First marketedMay 2022
Product typeDrug For Further Processing
Portfolio30 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It actually tackles two things at once. The fexofenadine part is an antihistamine that helps with allergy symptoms like runny nose, sneezing, itchy and watery eyes, and itching of...
  • What exactly does this medication do — does it just help with allergies?
  • Yes, it really does matter. You should take this tablet on an empty stomach with a full glass of water. Also, use water specifically — do not take it with fruit juice. Taking it wi...
  • Does it matter when I take it — like with food or on an empty stomach?
📖 Read our full Fexofenadine and Pseudoephedrine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 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 eachPer 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.
Try another pack size: 5 tablets 5 tablets 50000 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fexofenadine HCl and Pseudoephedrine HCl 180 mg/1; 240 mg 00363-0049-10 Walgreens 5 tablets — — Discontinued —
Allegra-D Allergy and Congestion 180 mg/1; 240 mg 41167-4320-05 Chattem, 5 tablets — — FDA listed —
Fexofenadine HCl and Pseudoephedrine HCl 180 mg/1; 240 mgthis 43598-0892-07 Dr.Reddy's 5 tablets — — Discontinued —
Fexofenadine HCl and Pseudoephedrine HCl 180 mg/1; 240 mg 51316-0018-10 CVS 5 tablets — — Discontinued —
Fexofenadine HCl and Pseudoephedrine HCI 180 mg/1; 240 mg 55111-0557-07 Dr.Reddy's 5 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 180 mg/1; 240 mg 58602-0844-60 Aurohealth 5 tablets — — FDA listed —
Fexofenadine HCl and Pseudoephedrine HCl 180 mg/1; 240 mg 79903-0255-10 Walmart 5 tablets — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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 approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

🔬 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 HCl and Pseudoephedrine HCl — the ingredient across all brands.

Top reported reactions

Completed Suicide4
Drug Interaction3
Acute Myocardial Infarction2
Diarrhoea2
Drug Toxicity2
Dyspnoea2
Fall2

Age at onset

Adult3

Reporter sex

29 reports
Male · 56%
Female · 44%

Serious outcomes

Hospitalization7
Death7
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
43598-0892-07 You're viewing this 1 BLISTER PACK in 1 CARTON (43598-892-07) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK — — 2022-05-17 Discontinued by firm
43598-0892-29 3 BLISTER PACK in 1 CARTON (43598-892-29) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK — — 2022-05-17 Discontinued by firm
43598-0892-35 2 BLISTER PACK in 1 CARTON (43598-892-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.8669 / ea $8.67 2022-05-17 Discontinued by firm
43598-0892-00 50000 TABLET, EXTENDED RELEASE in 1 DRUM (43598-892-00) — — — Active

Pack size FAQ

What quantity is in NDC 43598-0892-07?
NDC 43598-0892-07 is a 5-count package — 1 blister pack in 1 carton / 5 tablet, extended release in 1 blister pack.
What is the difference between NDC 43598-0892-07 and NDC 43598-0892-00?
Both are Fexofenadine HCl and Pseudoephedrine 180 mg; 240 mg Tablet, Extended Release — the drug itself is identical. NDC 43598-0892-07 is the 5-count package, while NDC 43598-0892-00 is the 50000 tablets package.
What NDC number is used to bill for this package of Fexofenadine HCl and Pseudoephedrine 180 mg; 240 mg Tablet, Extended Release?
Bill NDC 43598-0892-07 — the 11-digit billing format is 43598089207. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging No longer marketed (per FDA listing data)

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Dr.Reddy's Laboratories Inc supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 43598-892-07, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43598-0892-07, written without dashes as 43598089207. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 43598-0892-07, the first segment (43598) is the labeler code FDA assigned to Dr.Reddy's Laboratories Inc; the middle segment (0892) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 5 tablets (43598-0892-29), 5 tablets (43598-0892-35), 50000 tablets (43598-0892-00). 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 Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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.

📄 Full FDA label FDA SPL

The complete FDA label for this product, 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
🎯 Indications and Usage 60 words ▾

Use(s) 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 temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 73 words ▾

Directions do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 24 hours on an empty stomach; do not take more than 1 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 ~1 min read ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have difficulty swallowing Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland 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) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless 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 12 words ▾

Active ingredient(s) Fexofenadine HCl USP, 180 mg Pseudoephedrine HCl USP, 240 mg

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide, water

🎯 Purpose 4 words ▾

Purpose Antihistamine Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43598-0891-10 · Dr. 43598-0893-30 · Dr. →
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.