Loratadine ODT 10 mg Tablet, Orally Disintegrating
by Rugby Laboratories · 3 BLISTER PACK in 1 CARTON (0536-1367-07) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
NDC 00536-1367-07
🏷️ FDA NDC (as labeled)
0536-1367-07
billing pads the labeler segment with a zero
OTC
Generic
On market
Non-controlled
🗂️ 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 →
🆔 Identity & classification
FDA NDC (as labeled)
0536-1367-07
Product NDC
0536-1367
11-digit billing NDC
00536136707
NCPDP billing unit
EA — each (per item)
RxCUI
311373
UNII
7AJO3BO7QN
Application #
ANDA208477
SPL Set ID
f59f3400-da77-4eb7-be02-842071d87fae
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2022-10-06
Route
ORAL
Dosage form
TABLET, ORALLY DISINTEGRATING
Substance
LORATADINE
GCN Seq No
030476
GCN
60521
HICL code
007605
Ingredient (HICL)
Loratadine
HIC1 code
Z
Therapeutic class — broad (HIC1)
Body As A Whole
HIC2 code
Z2
Therapeutic class — intermediate (HIC2)
Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code
Z2Q
Therapeutic class — specific (HIC3)
Antihistamines - 2Nd Generation
AHFS code
04:08.00.00
AHFS class
Second Generation Antihistamines
FDB label name
LORATADINE 10 MG ODT
FDB brand name
Loratadine
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0536-1367-07 — a 4-4-2 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 labeler segment → 00536-1367-07. 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.
🏷️ 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
LabelerRugby Laboratories
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA208477 (ANDA)
Labeler code00536
First marketedOct 2022
Product typeHuman Otc Drug
Portfolio149 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 LORATADINE 10 MG ODT Ingredient Loratadine
📖 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
- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Loratadine — tap one for details:
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?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White
ShapeRound
ImprintK;9
Size8 mm
ScoringNot scored
FlavorPeppermint
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 Z0H242BBR1
Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
-
UNII 68401960MK
Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
-
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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII V95R5KMY2B
Peppermint is a flavoring agent derived from the peppermint plant. It's added to medicines to improve taste and mask bitter or unpleasant flavors, making them easier to take.
-
UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
-
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.
7 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesaspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch (maize), sodium stearyl fumarate
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.533 | $15.98 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.7908 | $23.72 / 30 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 50% over the last 11 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 |
|---|---|---|---|---|---|---|
| Loratadine ODT 10 mgthis 00536-1367-07 | Rugby | 10 tablets | $0.533 | — | Availability likely | — |
| Loratadine ODT 10 mg 46122-0539-52 | Amerisource | 10 tablets | $0.533 | — | Availability likely | — |
| Loratadine 10 mg 72888-0029-09 | Advagen | 10 tablets | $0.533 | — | Availability likely | — |
| good sense allergy relief 10 mg 00113-1191-65 | L. | 1 tablet | — | — | FDA listed | — |
| good sense allergy relief 10 mg 00113-9755-65 | L. | 1 tablet | — | — | FDA listed | — |
| Childrens Loratadine Odt 10 mg 00363-4020-84 | WALGREEN | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 00363-9937-84 | WALGREEN | 10 tablets | — | — | FDA listed | — |
| Claritin Reditabs 10 mg 11523-4329-01 | Bayer | 10 tablets | — | — | FDA listed | — |
| Claritin Reditabs 10 mg 11523-7157-02 | Bayer | 10 tablets | — | — | FDA listed | — |
| loratadine 10 mg 11822-0558-00 | Rite | 1 tablet | — | — | FDA listed | — |
| loratadine 10 mg 11822-0919-00 | Rite | 1 tablet | — | — | Discontinued | — |
| Loratadine ODT 10 mg 21130-0221-84 | Better | 10 tablets | — | — | FDA listed | — |
| signature care allergy relief 10 mg 21130-0301-65 | Safeway | 1 tablet | — | — | Discontinued | — |
| signature care allergy relief 10 mg 21130-0452-65 | Safeway | 1 tablet | — | — | FDA listed | — |
| allergy relief 10 mg 30142-0446-65 | Kroger | 1 tablet | — | — | FDA listed | — |
| Topcare Allergy Relief 10 mg 36800-0853-65 | Topco | 1 tablet | — | — | FDA listed | — |
| non drowsy allergy relief 10 mg 41250-0890-65 | Meijer | 1 tablet | — | — | FDA listed | — |
| careone allergy relief 10 mg 41520-0510-65 | American | 1 tablet | — | — | FDA listed | — |
| Loratadine 10 mg 43598-0707-30 | Dr. | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 43598-0758-10 | Dr. | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 49035-0806-03 | Wal-Mart | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 51316-0503-01 | CVS | 10 tablets | — | — | FDA listed | — |
| Allergy Relief 10 mg 51316-0931-46 | CVS | 1 tablet | — | — | FDA listed | — |
| Allergy Relief 10 mg 51660-0527-31 | Ohm | 1 tablet | — | — | FDA listed | — |
| Loratadine ODT 10 mg 53943-0035-03 | DISCOUNT | 10 tablets | — | — | FDA listed | — |
| dg health allergy relief 10 mg 55910-0594-46 | Dolgencorp, | 1 tablet | — | — | FDA listed | — |
| dg health allergy relief 10 mg 55910-0970-46 | Dolgencorp, | 1 tablet | — | — | FDA listed | — |
| Allervarx 10 mg 57483-0950-10 | Innovus | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0744-83 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0821-83 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0830-83 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0881-15 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 59556-0917-01 | Strides | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 60000-0950-83 | Ahold | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 68016-0088-10 | Chain | 10 tablets | — | — | FDA listed | — |
| Alavert Allergy 10 mg 69536-0190-60 | Foundation | 1 tablet | — | — | FDA listed | — |
| Alavert Allergy 10 mg 69536-0195-20 | Foundation | 1 tablet | — | — | FDA listed | — |
| Loratadine ODT 10 mg 69842-0085-03 | CVS | 10 tablets | — | — | FDA listed | — |
| Basic Care Allergy Relief 10 mg 72288-0200-65 | Amazon.com | 1 tablet | — | — | FDA listed | — |
| Basic Care Allergy Relief 10 mg 72288-0451-65 | Amazon.com | 1 tablet | — | — | FDA listed | — |
| Loratadine 10 mg 72983-0501-01 | Tenshi | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 72983-0503-06 | Tenshi | 1 tablet | — | — | FDA listed | — |
| equate loratadine 10 mg 79903-0381-10 | WALMART | 1 tablet | — | — | FDA listed | — |
| Alavert Allergy 10 mg 80070-0110-18 | Foundation | 1 tablet | — | — | FDA listed | — |
| Alavert Allergy 10 mg 80070-0120-60 | Foundation | 1 tablet | — | — | FDA listed | — |
| Allergy Relief 10 mg 79481-9723-01 | Meijer, | 1 tablet | — | — | 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
🏛️
2022
On the market since
Oct 2022
📍
2026
Currently FDA-listed
4 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 00536-1367-07, 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 – Q4 2025 · 4 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
3.1K
Units reimbursed last 4 qtrs
92.7K
Gross reimbursed last 4 qtrs
$73.3K
Avg / prescription
$23.80
Avg / unit
$0.7908
Latest quarter Q4 2025
943Rx
Medicaid pays / ea
$0.7908
gross reimbursed
vs
NADAC / ea
$0.5326
acquisition cost
=
Spread
+$0.2582
+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 · 1,197 Rx Managed care · 1,883 Rx
State Medicaid map
Units reimbursed · per 100k residents
1.3153
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.
🔬 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 ODT (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 36%
Female · 64%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00536-1367-07 You're viewing this | 3 BLISTER PACK in 1 CARTON (0536-1367-07) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2022-10-06 | 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses 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
⏱️ Dosage and Administration ▾
Directions place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
⚠️ Warnings ▾
Warnings
📦 Storage and Handling ▾
Other information Phenylketonurics: Contains phenylalanine 2.25 mg per tablet do not use if the individual blister unit is open or torn store at 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister Complies with USP test 2 for Disintegration
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Loratadine USP 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch (maize), sodium stearyl fumarate
🎯 Purpose ▾
Purpose Antihistamine
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.