HomeNDC LookupIngredientsClemastine Fumarate › 64950-0268-10
image loading
(from DailyMed)

Clemastine Fumarate 2.68 mg Tablet, 100-count

by Genus Lifesciences · 100 TABLET in 1 BOTTLE (64950-268-10)
NDC 64950-0268-10
🏷️ FDA NDC (as labeled) 64950-268-10 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$3.20 NADAC Per package$320.39 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $2.06/unit · Part D plans $3.32/unit — full pricing hub ↓
Also comes in: 30 tablets 64950-0268-03
Rx only 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) 64950-268-10
Product NDC 64950-268
11-digit billing NDC 64950026810
NCPDP billing unit EA — each (per item)
RxCUI 857461
UNII 19259EGQ3D
Application # ANDA073283
SPL Set ID cf8a3449-8bb3-4d5c-8d0d-557590e49ee5
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-20
Route ORAL
Dosage form TABLET
Substance CLEMASTINE FUMARATE
GPI-14 41200020400310
GCN Seq No 011656
GCN 46691
HICL code 004512
Ingredient (HICL) Clemastine Fumarate
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name CLEMASTINE FUM 2.68 MG TABLET
FDB brand name Clemastine Fumarate
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 64950-268-10 — 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 → 64950-0268-10. 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 Antihistamines for topical use class.

Drug family (ATC) Antihistamines for topical use, Aminoalkyl ethers
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

LabelerGenus Lifesciences
Application holderGENUS LIFESCIENCES INC
FDA applicationANDA073283 (ANDA)
Labeler code64950
First marketedNov 2024
Product typeHuman Prescription Drug
Portfolio25 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 CLEMASTINE FUM 2.68 MG TABLET Ingredient Clemastine Fumarate
📗 Our plain-language guide HelloPharmacist
  • Clemastine is an antihistamine used to relieve the classic symptoms of allergies — sneezing, runny nose, itchy eyes, and watery eyes. It's also used to treat mild hives (urticaria)...
  • Yes — drowsiness is the most common side effect, and it can be significant. You should avoid driving, operating machinery, or anything that requires full alertness until you know h...
  • The oral solution (Clemastine Fumarate syrup) is indicated for children aged 6 through 12 for allergic rhinitis and hives. The tablet form has not been established as safe and effe...
  • Yes — let your doctor know if you have an enlarged prostate, trouble urinating, narrow-angle glaucoma, a stomach ulcer, or any bowel obstruction. These conditions can get worse wit...
📖 Read our full Clemastine 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 White
ShapeRound
ImprintNH;268
Size1 mm
ScoringScored — splits in 2
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 J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • 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 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $3.204 $320.39 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $2.06 $206.19 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $3.32 $332.10 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2026 Mar 2026 May 2026 Aug 2026 $3.356 $3.204
▼ Down 4% over the last 8 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clemastine Fumarate 2.68 mgthis 64950-0268-10 Genus 100 tablets $3.204 Availability likely
Clemsza 2.68 mg 71085-0081-30 IPG 30 tablets $3.204 Availability likely
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

🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 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 64950-0268-10, 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
199
Units reimbursed last 4 qtrs
10.5K
Gross reimbursed last 4 qtrs
$21.7K
Avg / prescription
$109.08
Avg / unit
$2.0619
Latest quarter Q4 2025
78Rx
Medicaid pays / ea
$2.0619
gross reimbursed
vs
NADAC / ea
$3.2039
acquisition cost
=
Spread
−$1.1420
-36% 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
45% FFS 55% MCO
Fee-for-service · 90 Rx Managed care · 109 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 2,022 units · 10.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 944 units · 16.1 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 330 units · 7.3 per 100k residents KY West Virginia: no data reported WV Virginia: 780 units · 8.9 per 100k residents VA Maryland: no data reported MD Connecticut: 1,005 units · 27.8 per 100k residents CT Rhode Island: no data reported RI Arizona: 2,320 units · 31.2 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 480 units · 9.4 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 2,646 units · 11.7 per 100k residents FL
Units reimbursed · per 100k residents
7.331.2
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
🏆 Top states by units · per 100k residents
1 Arizona 31.2 /100k
2 Connecticut 27.8 /100k
3 Colorado 16.1 /100k
4 Florida 11.7 /100k
5 New York 10.3 /100k
6 Alabama 9.4 /100k
7 Virginia 8.9 /100k
8 Kentucky 7.3 /100k
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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets64950-0268-03 No Medicaid data
Drug total (last 4 qtrs): 199 Rx · 10,527 units · $21,706 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clemastine Fumarate — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clemastine Fumarate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.17M
Claims incl. refills
1.9K
Beneficiaries
982
Spend / beneficiary
$6,287.79
Spend / claim
$3,330.43
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
64950-0268-03 30 TABLET in 1 BOTTLE (64950-268-03) 2024-11-20 Active
64950-0268-10 You're viewing this 100 TABLET in 1 BOTTLE (64950-268-10) $3.20 / ea $320.39 2024-11-20 Active

You're viewing the largest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 64950-0268-10?
NDC 64950-0268-10 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 64950-0268-10 and NDC 64950-0268-03?
Both are Clemastine Fumarate 2.68 mg Tablet — the drug itself is identical. NDC 64950-0268-10 is the 100-count package, while NDC 64950-0268-03 is the 30 tablets package.
What NDC number is used to bill for this package of Clemastine Fumarate 2.68 mg Tablet?
Bill NDC 64950-0268-10 — the 11-digit billing format is 64950026810. 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 69 words

INDICATIONS AND USAGE Clemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.

⏱️ Dosage and Administration 52 words

DOSAGE AND ADMINISTRATION DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT. Clemastine Fumarate Tablets 2.68 mg The maximum recommended dosage is one tablet three times daily. Many patients respond favorably to a single dose which may be repeated as required, but not to exceed three tablets daily.

Contraindications 74 words

CONTRAINDICATIONS Usage in Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Usage in Lower Respiratory Disease Antihistamines should not be used to treat lower respiratory tract symptoms including asthma. Antihistamines are also contraindicated in the following conditions: Hypersensitivity to clemastine fumarate or other antihistamines of similar chemical structure.

Monoamine oxidase inhibitor therapy (see Drug Interactions section).

⚠️ Warnings 140 words

WARNINGS Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. Usage in Children Safety and efficacy of clemastine fumarate have not been established in children under the age of 12 years. Usage in Pregnancy Experience with this drug in pregnant women is inadequate to determine whether there is exists a potential for harm to the developing fetus.

Usage with CNS Depressants Clemastine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.). Usage in Activities Requiring Mental Alertness Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc. Usage in the Elderly (approximately 60 years or older) Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

🤒 Adverse Reactions 155 words

ADVERSE REACTIONS Transient drowsiness, the most common adverse reaction associated with clemastine fumarate, occurs relatively frequently and may require discontinuation of therapy in some instances. Antihistaminic Compounds It should be noted that the following reactions have occurred with one or more antihistamines and, therefore, should be kept in mind when prescribing drugs belonging to this class, including clemastine. The most frequent adverse reactions are italicized.

General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose, and throat. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

Nervous System: Sedation, sleepiness, dizziness, disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. GU System: Urinary frequency, difficult urination, urinary retention, early menses.

Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

🔄 Drug Interactions 13 words

Drug Interactions MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

🆘 Overdosage 159 words

OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms: dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur.

If vomiting has not occurred spontaneously the conscious patient should be induced to vomit. This is best done by having him drink a glass of water or milk after which he should be made to gag. Precautions against aspiration must be taken, especially in infants and children.

If vomiting is unsuccessful gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand. Isotonic and 1/2 isotonic saline is the lavage solution of choice. Saline cathartics , such as milk of magnesia, by osmosis draw water into the bowel and therefore, are valuable for their action in rapid dilution of bowel content.

Stimulants should not be used. Vasopressors may be used to treat hypotension.

🧬 Clinical Pharmacology 130 words

CLINICAL PHARMACOLOGY Clemastine fumarate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. The inherently long duration of antihistaminic effects of clemastine fumarate has been demonstrated in wheal and flare studies.

In normal human subjects who received histamine injections over a 24-hour period, the antihistaminic activity of clemastine reached a peak at 5 to 7 hours, persisted for 10 to 12 hours and, in some cases, for as long as 24 hours. Pharmacokinetic studies in man utilizing 3 H and 14 C labeled compound demonstrates that: clemastine is rapidly and nearly completely absorbed from the gastrointestinal tract, peak plasma concentrations are attained in 2 to 4 hours, and urinary excretion is the major mode of elimination.

📦 How Supplied / Storage and Handling 61 words

HOW SUPPLIED Clemastine Fumarate Tablets USP, 2.68 mg are white, round, scored tablets debossed with "NH" and "268". Tablets are packaged in bottles of 30 (NDC 64950-268-03) and 100 (NDC 64950-268-10) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

📦 Storage and Handling 30 words

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

📋 Description 65 words

DESCRIPTION Clemastine belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2 R )-2-[2-[[( R )- p -Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1). C 21 H 26 C1NO∙C 4 H 4 O 4 M.W.

459.97 Each tablet for oral administration contains 2.68 mg of clemastine fumarate, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch and stearic acid. Chemical Structure

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.