Loratadine and Pseudoephedrine 10 mg; 240 mg Tablet, Extended Release, 15-count
by AMERISOURCE BERGEN · 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46122-383-22)
NDC 46122-0383-22
🏷️ FDA NDC (as labeled)
46122-383-22
billing pads the product segment with a zero
OTC
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
46122-383-22
Product NDC
46122-383
11-digit billing NDC
46122038322
NCPDP billing unit
EA — each (per item)
RxCUI
1117562
UNII
7AJO3BO7QN, Y9DL7QPE6B
Application #
ANDA076557
SPL Set ID
96635cb0-8c78-4c3a-8294-2804ff26f90a
Established class (EPC)
alpha-Adrenergic Agonist
Mechanism of action
Adrenergic alpha-Agonists
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-08-02
Route
ORAL
Dosage form
TABLET, EXTENDED RELEASE
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
GPI-14
43993002597520
GPI class
GNP Allergy/Congestion Relief
GCN Seq No
027622
GCN
63577
HICL code
006605
Ingredient (HICL)
Loratadine/Pseudoephedrine
HIC1 code
Z
Therapeutic class — broad (HIC1)
Body As A Whole
HIC2 code
Z2
Therapeutic class — intermediate (HIC2)
Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code
Z2O
Therapeutic class — specific (HIC3)
2Nd Gen Antihistamine And Decongestant Combination
AHFS code
04:08.00.00
AHFS class
Second Generation Antihistamines
FDB label name
ALLERGY-CONGES RELF ER TABLET
FDB brand name
Allergy-Congestion Relief
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 46122-383-22 — 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 → 46122-0383-22. 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 Other antihistamines for systemic use class.
Drug family (ATC)
Other antihistamines for systemic use
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.
🏭 Manufacturer & labeler
LabelerAMERISOURCE BERGEN
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA076557 (ANDA)
Labeler code46122
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio206 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
Label name ALLERGY-CONGES RELF ER TABLET Ingredient Loratadine/Pseudoephedrine
📖 What it is MedlinePlus · NLM
Loratadine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Loratadine 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.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Great question. The two ingredients each do something different. Loratadine is an antihistamine — it targets the sneezing, runny nose, itchy eyes, and throat itching that come with...
- What exactly does this medicine do, and why does it have two ingredients?
- You take it by mouth with a full glass of water — but it's really important that you swallow it whole. Do not crush, split, chew, or dissolve it. These are extended-release tablets...
- How do I take it, and does it matter if I crush or split the tablet?
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.
💬 Questions about loratadine and pseudoephedrine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeCapsule
ImprintRX724
Size17 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.
🧪 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.566 | $8.48 / 15 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.8394 | $12.59 / 15 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
▲ Up 11% 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| allergy d 10 mg/1; 240 mg 00113-9004-22 | L. | 1 tablet | $0.566 | — | Availability likely | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 00904-5833-15 | Major | 10 tablets | $0.566 | — | Availability likely | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 46122-0167-52 | Amerisource | 10 tablets | $0.566 | — | Availability likely | — |
| Loratadine and Pseudoephedrine 10 mg/1; 240 mgthis 46122-0383-22 | AMERISOURCE | 15 tablets | $0.566 | — | Availability likely | — |
| Loratadine and Pseudoephedrine 10 mg/1; 240 mg 51660-0724-04 | Ohm | 5 tablets | $0.566 | — | Availability likely | — |
| Leader Allergy Relief D-24 10 mg/1; 240 mg 70000-0162-01 | Cardinal | 10 tablets | $0.566 | — | Availability likely | — |
| Loratadine and Pseudoephedrine 10 mg/1; 240 mg 70677-1018-01 | STRATEGIC | 10 tablets | $0.566 | — | Availability likely | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 49348-0543-01 | STRATEGIC | 10 tablets | $0.574 | — | FDA listed | +2% |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 62011-0071-01 | Strategic | 10 tablets | $0.574 | — | FDA listed | +2% |
| Loratadine and Pseudoephedrine 10 mg/1; 240 mg 00363-0725-15 | Walgreen | 15 tablets | — | — | FDA listed | — |
| Allergy Relief D 10 mg/1; 240 mg 00363-2010-22 | Walgreen | 1 tablet | — | — | FDA listed | — |
| Claritin-D 24 Hour 10 mg/1; 240 mg 11523-0102-01 | Bayer | 10 tablets | — | — | FDA listed | — |
| Claritin-D 24 Hour 10 mg/1; 240 mg 11523-4332-01 | Bayer | 5 tablets | — | — | Discontinued | — |
| Loratadine and Pseudoephedrine 10 mg/1; 240 mg 11822-9990-00 | Rite | 10 tablets | — | — | FDA listed | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 21130-0724-15 | Safeway | 15 tablets | — | — | FDA listed | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 30142-0724-15 | The | 1 tablet | — | — | FDA listed | — |
| allergy congestion relief 10 mg/1; 240 mg 30142-0846-22 | Kroger | 1 tablet | — | — | FDA listed | — |
| topcare allergy and congestion relief 10 mg/1; 240 mg 36800-0706-22 | Topco | 1 tablet | — | — | FDA listed | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 37808-0427-69 | HEB | 10 tablets | — | — | FDA listed | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 37808-0724-69 | HEB | 10 tablets | — | — | FDA listed | — |
| Allergy Relief-D 240 mg/1; 10 mg 37808-0787-07 | HEB | 5 tablets | — | — | FDA listed | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 41250-0724-52 | Meijer | 15 tablets | — | — | FDA listed | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 49035-0488-15 | WAL-MART | 15 tablets | — | — | FDA listed | — |
| Loratadine and Pseudoephedrine 10 mg/1; 240 mg 51660-0491-15 | Ohm | 15 tablets | — | — | Discontinued | — |
| Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 56062-0724-15 | Publix | 15 tablets | — | — | FDA listed | — |
| Allergy Relief-D 10 mg/1; 240 mg 59779-0726-15 | CVS | 5 tablets | — | — | FDA listed | — |
| Loratadine and Pseudoephedrine 10 mg/1; 240 mg 63187-0305-10 | Proficient | 10 tablets | — | — | FDA listed | — |
| kirkland signature allerclear d 24 hr 10 mg/1; 240 mg 63981-0138-22 | Costco | 1 tablet | — | — | FDA listed | — |
| KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release 10 mg/1; 240 mg 63981-0724-15 | Kirkland-COSTCO | 15 tablets | — | — | FDA listed | — |
| Loratadine and Pseudoephedrine 10 mg/1; 240 mg 85766-0048-10 | Sportpharm | 10 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
🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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.
🗺️ 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 46122-0383-22, 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
170
Units reimbursed last 4 qtrs
4.5K
Gross reimbursed last 4 qtrs
$3.8K
Avg / prescription
$22.26
Avg / unit
$0.8394
Latest quarter Q1 2026
36Rx
Medicaid pays / ea
$0.8394
gross reimbursed
vs
NADAC / ea
$0.5656
acquisition cost
=
Spread
+$0.2738
+48% 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 ⓘ
Fee-for-service · 84 Rx Managed care · 86 Rx
State Medicaid map
Units reimbursed · per 100k residents
5.419.1
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46122-0383-22 You're viewing this | 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46122-383-22) | 2017-08-02 | Active |
📄 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
🎯 Indications and Usage ▾
Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily restores freer breathing through the nose
⏱️ Dosage and Administration ▾
Directions • do not divide, crush, chew or dissolve the tablet • adults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours • children under 12 years of age: ask a doctor • consumers with liver or kidney disease: ask a
⚠️ Warnings ▾
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 Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease.
Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness Stop use and ask a 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 nervousness • dizziness or sleeplessness If pregnant or breast-feeding, ask a health professional before use.
🧪 Active Ingredient ▾
Active ingredient Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240
🧪 Inactive Ingredients ▾
Inactive ingredients calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
🎯 Purpose ▾
Purpose Antihistamine Nasal decongestant
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 ↗
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.