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Loratadine 10 mg Capsule, Liquid Filled, 600-count

by MARKSANS PHARMA LIMITED · 600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13)
NDC 25000-0021-13
🏷️ FDA NDC (as labeled) 25000-021-13 billing pads the product segment with a zero
This package
Contains600-count Pack sizes6 compare ↓
Also comes in: 8 capsules 25000-0021-46 10 capsules 25000-0021-36 28 capsules 25000-0021-34 100 capsules 25000-0021-08 7500 capsules 25000-0021-21
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 25000-021-13
Product NDC 25000-021
11-digit billing NDC 25000002113
RxCUI 828269
UNII 7AJO3BO7QN
UPC 0325000021368, 0325000021344
Application # ANDA206214
SPL Set ID c30907f9-1761-41e5-bd4e-2613e756e1c6
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-10-01
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance LORATADINE
Why two NDCs? The FDA registers this code as 25000-021-13 — 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 → 25000-0021-13. 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

LabelerMARKSANS PHARMA LIMITED
Application holderMARKSANS PHARMA LTD
FDA applicationANDA206214 (ANDA)
Labeler code25000
First marketedOct 2016
Product typeHuman Otc Drug
Portfolio62 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
  • Loratadine is an antihistamine that temporarily relieves common allergy symptoms — things like a runny nose, sneezing, itchy or watery eyes, and an itchy nose or throat. It works f...
  • When taken as directed, loratadine is considered non-drowsy for most people. However, if you take more than the recommended daily amount, drowsiness can happen. So stick to the dos...
  • It depends on the age. Children 6 and older can take standard adult doses of most forms. Children 2 to under 6 can use the oral solution or chewable tablets, but at a lower amount....
  • You should check with your doctor before taking loratadine if you have liver or kidney disease. Your doctor may need to adjust your dose. It's not necessarily off-limits, but it's...
📖 Read our full Loratadine guide →
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.

💊 What it looks like

Color Blue
ShapeOval
Imprint21
Size3 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 4G9EDB6V73
    Capric acid is a fatty acid derived from natural sources like coconut oil. It acts as a surfactant and emulsifier, helping blend ingredients that normally don't mix, and may improve how the body absorbs the medicine.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesFD&C blue no. 1, gelatin, mono and diglyceride of caprylic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution. Questions or comments? Call at 1-877-376-4271

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.

💲 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 mLPer 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: 8 capsules 10 capsules 28 capsules 100 capsules 7500 capsules
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
Wal-Itin 10 mg 00363-1686-07 WALGREENS 10 capsules — — FDA listed —
Claritin Liqui-Gels 10 mg 11523-7200-01 Bayer 10 capsules — — Discontinued —
Claritin Liqui-Gels 10 mg 11523-7333-01 Bayer 5 capsules — — Discontinued —
Allergy Relief 10 mg 11673-0986-07 TARGET 10 capsules — — FDA listed —
Allergy Relief 10 mg 21130-0195-02 Safeway 10 capsules — — FDA listed —
Loratadine 10 mgthis 25000-0021-13 MARKSANS 600 capsules — — FDA listed —
topcare allergy relief 10 mg 36800-0755-39 Topco 1 capsule — — FDA listed —
Loratadine 10 mg 41226-0686-30 KROGER 30 capsules — — FDA listed —
Loratadine 10 mg 49483-0686-07 TIME 10 capsules — — FDA listed —
Loratadine 10 mg 49738-0686-07 SMART 10 capsules — — FDA listed —
Allergy Relief 10 mg 50804-0840-10 GOODSENSE 10 capsules — — Discontinued —
dg health allergy relief 10 mg 55910-0629-39 Dolgencorp 1 capsule — — Discontinued —
Loratadine 10 mg 58602-0818-05 Aurohealth 10 capsules — — FDA listed —
Allergy Relief 10 mg 63868-0669-10 CHAIN 10 capsules — — Discontinued —
Loratadine 10 mg 69452-0211-03 Bionpharma 5 capsules — — FDA listed —
Loratadine 10 mg 69842-0686-07 CVS 10 capsules — — FDA listed —
Allergy Relief 10 mg 70000-0755-01 CARDINAL 1 capsule — — FDA listed —
Basic Care Allergy Relief 10 mg 72288-0446-39 Amazon.com 1 capsule — — FDA listed —
allergy relief 10 mg 79481-0446-00 Meijer, 1 capsule — — FDA listed —
Allergy Relief 10 mg 83324-0103-10 CHAIN 10 capsules — — FDA listed —
Loratadine 10 mg 69452-0283-17 Bionpharma 60 capsules — — Discontinued —
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

🏛️
2016
On the market since
Oct 2016
📍
2026
Currently FDA-listed
10 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.

🔬 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 LORATADINE — the ingredient across all brands.

Top reported reactions

Fatigue6,880
Nausea6,108
Headache5,618
Dyspnoea5,027
Diarrhoea4,995
Dizziness4,683
Pain4,258

Age at onset

Neonate39
Infant137
Child2,951
Adolescent762
Adult13,205
Elderly8,007

Reporter sex

114,197 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization23,691
Death4,744
Life-threatening2,561
Disabling2,302
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,335 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 Marketing startStatus
25000-0021-08 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08) 2016-10-01 Active
25000-0021-13 You're viewing this 600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13) 2016-10-01 Active
25000-0021-21 4 BAG in 1 BOX (25000-021-21) / 7500 CAPSULE, LIQUID FILLED in 1 BAG 2016-10-01 Active
25000-0021-34 28 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (25000-021-34) 2016-10-01 Active
25000-0021-36 3 BLISTER PACK in 1 CARTON (25000-021-36) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2020-10-17 Active
25000-0021-46 8 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-46) 2016-10-01 Active

Pack size FAQ

What quantity is in NDC 25000-0021-13?
NDC 25000-0021-13 is a 600-count package — 600 capsule, liquid filled in 1 bottle.
What is the difference between NDC 25000-0021-13 and NDC 25000-0021-46?
Both are Loratadine 10 mg Capsule, Liquid Filled — the drug itself is identical. NDC 25000-0021-13 is the 600-count package, while NDC 25000-0021-46 is the 8 capsules package.
What NDC number is used to bill for this package of Loratadine 10 mg Capsule, Liquid Filled?
Bill NDC 25000-0021-13 — the 11-digit billing format is 25000002113. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 FDA registers it as 25000-021-13, 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: 25000-0021-13, written without dashes as 25000002113. 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 25000-0021-13, the first segment (25000) is the labeler code FDA assigned to MARKSANS PHARMA LIMITED; the middle segment (0021) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (13) identifies this exact package size and type. Together they name one specific package of one specific product.
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 MARKSANS PHARMA 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 5 other package presentations of this same product, including 8 capsules (25000-0021-46), 10 capsules (25000-0021-36), 28 capsules (25000-0021-34). 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?
MARKSANS PHARMA 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.

📄 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 30 words ▾

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 41 words ▾

Directions Adults and children 6 years and over : 1 capsule daily; Not more than 1 capsule in 24 hours . Children under 6 years of age : ask a doctor. Consumers with liver or kidney disease : ask a doctor.

⚠️ Warnings 20 words ▾

WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

🧪 Active Ingredient 7 words ▾

Active ingredient (in each capsule) Loratadine 10mg

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients FD&C blue no. 1, gelatin, mono and diglyceride of caprylic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution. Questions or comments? Call at 1-877-376-4271

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 25000-0017-03 · MARKSANS 25000-0041-12 · MARKSANS →
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.