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CLEMASTINE FUMARATE .67 mg/5mL Syrup, 120 mL — NDC 62135-0713-41 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CLEMASTINE FUMARATE .67 mg/5mL Syrup, 120 mL — NDC 62135-713-41 (Billing 62135-0713-41)

by Chartwell RX, LLC · 120 mL in 1 BOTTLE

This is a package of 120 mL of CLEMASTINE FUMARATE .67 mg/5mL Syrup from Chartwell RX, LLC, marketed since Dec 1997 and currently FDA-listed. It is this product's only package size.

NDC 62135-0713-41
🏷️ FDA NDC (as labeled) 62135-713-41 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-713-41
Product NDC 62135-713
11-digit billing NDC 62135071341
NCPDP billing unit ML — per mL (volume)
RxCUI 857430
UNII 19259EGQ3D
UPC 0362135713416
Application # ANDA074884
SPL Set ID 6663f1b0-5353-401f-b9d3-d9f69ad08fbf
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1997-12-17
Route ORAL
Dosage form SYRUP
Substance CLEMASTINE FUMARATE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 011654
GCN 46990
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 0.5 MG/5 ML SYRUP
FDB brand name Clemastine Fumarate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 011654
  • GCN: 46990
  • HICL (First Databank): 004512
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 857430
Why two NDCs? The FDA registers this code as 62135-713-41 — 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 → 62135-0713-41. 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.

Clinical

Label name CLEMASTINE 0.5 MG/5 ML SYRUP Ingredient Clemastine Fumarate
📖 What it is MedlinePlus · NLM

Clemastine is used to treat allergy symptoms: runny nose sneezing itching of the nose or throat red, itchy, or watery eyes Clemastine is also used to relieve the itching and swelling of hives. Clemastine 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
  • It relieves allergy symptoms like sneezing, runny nose, itching and watery eyes. It is also used for mild allergic skin reactions such as hives and angioedema, at the higher dosage...
  • Quite possibly. Drowsiness is the most common side effect. Wait to see how it affects you before driving or using machinery, and avoid alcohol and other sedating medicines because...
  • You take it by mouth, as a syrup or tablet. The syrup is generally taken twice daily, and the tablets up to three times daily at most. Your prescriber will tailor the dose, so foll...
  • If you are breastfeeding, no. The label says antihistamines are contraindicated for nursing mothers because of higher risk to infants. For pregnancy, there is not enough experience...
📖 Read our full Clemastine 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.

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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62135-0713-41 You're viewing this Main listing 120 mL in 1 BOTTLE 2023-07-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clemastine Fumarate .67 mg/5mL 64950-0324-12 Genus 120 ml $5.492 AA Availability likely —
Clemastine Fumarate .67 mg/5mLthis 62135-0713-41 Chartwell 120 ml — AA 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

🏛️
1997
On the market since
Dec 1997
📍
2026
Currently FDA-listed
29 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.

What it looks like

FlavorCherry
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 88XHZ13131
    Fumaric acid is an organic acid used in medications as a buffer and pH regulator. It helps maintain the proper acidity level in the medicine and may aid in tablet disintegration.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

9 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 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.

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderNEW HEIGHTSRX LLC
FDA applicationANDA074884 (ANDA)
Labeler code62135
First marketedDec 1997
Product typeHuman Prescription Drug
Portfolio521 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.

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 75 words ▾

INDICATIONS AND USAGE Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION ). It should be noted that clemastine fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.

⏱️ Dosage and Administration 158 words ▾

DOSAGE AND ADMINISTRATION DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT. Pediatric: Children aged 6 to 12 years: For Symptoms Of Allergic Rhinitis -The starting dose is 1 teaspoonful (0.5 mg clemastine) twice daily. Since single doses of up to 2.25 mg clemastine were well tolerated by this age group, dosage may be increased as required, but not to exceed 6 teaspoonfuls daily (3 mg clemastine).

For Urticaria and Angioedema -The starting dose is 2 teaspoonfuls (1 mg clemastine) twice daily, not to exceed 6 teaspoonfuls daily (3 mg clemastine). Adults and Children 12 years and Over: For Symptoms Of Allergic Rhinitis -The starting dose is 2 teaspoonfuls (1.0 mg clemastine) twice daily. Dosage may be increased as required, but not to exceed 12 teaspoonfuls daily (6 mg clemastine).

For Urticaria and Angioedema -The starting dose is 4 teaspoonfuls (2 mg clemastine) twice daily, not to exceed 12 teaspoonfuls daily (6 mg clemastine).

⛔ Contraindications 64 words ▾

CONTRAINDICATIONS Antihistamines are contraindicated in patients hypersensitive to the drug or to other antihistamines of similar chemical structure (see PRECAUTIONS - Drug Interactions ). Antihistamines should not be used in newborn or premature Infants. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers (See PRECAUTIONS - Nursing Mothers ).

⚠️ Warnings 94 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. Use with CNS Depressants: Clemastine fumarate has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.) Use 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.

Use in the Elderly (approximately 60 years or older): Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

🤒 Adverse Reactions 101 words ▾

ADVERSE REACTIONS The most frequent adverse reactions are underlined: Nervous System: Sedation, sleepiness, dizziness, disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal System: Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System: Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness.

Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Genitourinary System: Urinary frequency, difficult urination, urinary retention, early menses.

General : Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat.

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. In children, stimulation predominates initially in a syndrome which may include excitement, hallucinations, ataxia, incoordination, muscle twitching, athetosis, hyperthermia, cyanosis convulsions, tremors, and hyperreflexia followed by postictal depression and cardio respiratory arrest. Convulsions in children may be preceded by mild depression.

Dry mouth, fixed dilated pupils, flushing of the face, and fever are common. In adults, CNS depression, ranging from drowsiness to coma, is more common. The convulsant dose of antihistamines lies near the lethal dose.

Convulsions indicate a poor prognosis. In both children and adults, coma and cardiovascular collapse may occur. Deaths are reported especially in infants and children.

There is no specific therapy for acute overdosage with antihistamines. The latent period from ingestion to appearance of toxic effects is characteristically short (1/2-2 hours). General symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary.

Since overdoses of other classes of drugs (i.e., tricyclic antidepressants) may also present anticholinergic symptomatology, appropriate toxicological analysis should be performed as soon as possible to identify the causative agent. In the conscious patient, vomiting should be induced even though it may have occurred spontaneously. If vomiting cannot be induced, gastric lavage is indicated.

Adequate precautions must be taken to protect against aspiration, especially in infants and children. Charcoal slurry or other suitable agents should be instilled into the stomach after vomiting or lavage. Saline cathartics or milk of magnesia may be of additional benefit.

In the unconscious patient, the airway should be secured with a cuffed endotracheal tube before attempting to evacuate the gastric contents. Intensive supportive and nursing care is indicated, as for any comatose patient. If breathing is significantly impaired, maintenance of an adequate airway and mechanical support of respiration is the most effective means of providing adequate oxygenation.

Hypotension is an early sign of impending cardiovascular collapse and should be treated vigorously. Although general supportive measures are important, specific treatment with intravenous infusion of a vasopressor titrated to maintain adequate blood pressure may be necessary. Do not use with CNS stimulants.

Convulsions should be controlled by careful administration of diazepam or a short-acting barbiturate, repeated as necessary. Physostigmine may also be considered for use in controlling centrally mediated convulsions. Ice packs and cooling sponge baths, not alcohol, can aid in reducing the fever commonly seen in children.

A more detailed review of antihistamine toxicology and overdose management is available in Gosselin, R.E., et al., "Clinical Toxicology of Commercial Products."

🧬 Clinical Pharmacology 104 words ▾

CLINICAL PHARMACOLOGY Clemastine fumarate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines competitively antagonize various physiological effects of histamine including increased capillary permeability and dilatation, the formation of edema, the "flare" and "itch" response, and gastrointestinal and respiratory smooth muscle constriction. Within the vascular tree, H1-receptor antagonists inhibit both the vasoconstrictor and vasodilator effects of histamine.

Depending on the dose, H1- receptor antagonists can produce CNS stimulation or depression. Most antihistamines exhibit central and/or peripheral anticholinergic activity. Antihistamines act by competitively blocking H1-receptor sites.

Antihistamines do not pharmacologically antagonize or chemically inactivate histamine, nor do they prevent the release of histamine.

📦 How Supplied / Storage and Handling 67 words ▾

HOW SUPPLIED Clemastine Fumarate Syrup: clemastine 0.5 mg/5 mL (present as clemastine fumarate, USP 0.67 mg/5 mL). A clear, colorless liquid with wild cherry flavor, in 120 mL bottle. 120 mL bottle (NDC 62135-713-41) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71572 Rev. 07/2023

📋 Description 120 words ▾

DESCRIPTION Each teaspoonful (5 mL) of Clemastine Fumarate Syrup for oral administration contains clemastine 0.5 mg (present as clemastine fumarate, USP 0.67 mg). Other ingredients: alcohol 5.5% v/v, wild cherry flavor, fumaric acid, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, and sorbitol solution. Clemastine fumarate belongs to the benzhydryl ether group of antihistaminic compounds.

The chemical name is (+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]- oxy]ethyl]-1-methylpyrrolidine fumarate and has the following structural formula: C 21 H 26 CINO.C 4 H 4 O 4 M.W. 459.97 CAS Registration Number 145976-57-9 Clemastine fumarate occurs as a colorless to faintly yellow, practically odorless, crystalline powder. Clemastine Fumarate Syrup is a clear, colorless liquid with wild cherry flavor and has an approximate pH of 6.2. "Image Description"

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General : Clemastine fumarate should be used with caution in patients with: history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, and hypertension. Information for Patients: Patients taking antihistamines should receive the following information and instructions: Antihistamines are prescribed to reduce allergic symptoms. Patients should be questioned regarding a history of glaucoma, peptic ulcer, urinary retention, or pregnancy before starting antihistamine therapy.

Patients should be told not to take alcohol, sleeping pills, sedatives, or tranquilizers while taking antihistamines. Antihistamines may cause drowsiness, dizziness, dry mouth, blurred vision, weakness, nausea, headache, or nervousness in some patients. Patients should avoid driving a car or working with hazardous machinery until they assess the effects of this medicine.

Patients should be told to store this medicine in a tightly closed container in a dry, cool place away from heat or direct sunlight and out of the reach of children. Drug Interactions Additive CNS depression may occur when antihistamines are administered concomitantly with other CNS depressants including barbiturates, tranquilizers, and alcohol. Patients receiving antihistamines should be advised against the concurrent use of other CNS depressant drugs.

Monoamine oxidase (MAO) inhibitors prolong and intensify the anticholinergic effects of antihistamines. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis : In a 2-year oral study in the rat at a dose of 84 mg/kg (about 500 times the adult human dose) and an 85-week oral study in the mouse at 206 mg/kg (about 1300 times the adult human dose), clemastine fumarate showed no evidence of carcinogenesis. No mutagenic studies have been conducted with clemastine fumarate.

Impairment of Fertility : Oral doses of clemastine fumarate in the rat produced a decrease in mating ability of the male at 312 times the adult human dose. This effect was not found at 156 times the adult human dose. Pregnancy Pregnancy Category B: Oral reproduction studies performed with clemastine fumarate in rats and rabbits at doses up to 312 and 188 times the adult human doses respectively, have revealed no evidence of teratogenic effects.

There are no adequate and well-controlled studies of Clemastine Fumarate Syrup in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. Nursing Mothers Although quantitative determination of antihistaminic drugs in breast milk have not been reported, qualitative tests have documented the excretion of diphenhydramine, pyrilamine, and tripelennamine in human milk.

Because of the potential for adverse reactions in nursing infants from antihistamines, a decision should be made whether to discontinue nursing or to discontinue the drug. Pediatric Use The safety and efficacy of Clemastine Fumarate Syrup has been confirmed in the pediatric population (age 6 years through 12). Safety and dose tolerance studies have confirmed children 6 through 11 years tolerated dosage ranges of 0.75 to 2.25 mg clemastine.

In infants and children particularly, antihistamines in overdosage may produce hallucinations, convulsions, and death. Symptoms of antihistamine toxicity in children may include fixed dilated pupils, flushed face, dry mouth, fever, excitation, hallucinations, ataxia, incoordination, athetosis, tonic-clonic convulsions, and postictal depression (see OVERDOSAGE ).

📄 Package Label / Principal Display Panel 17 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Clemastine Fumarate Syrup, 0.5mg/5ml - NDC-62135-713-41 - 120 ml Bottle label. "Image Description"

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.

About this NDC listing & data coverage

Finished prescription 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 ✓ Available
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 ✓ Available
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Chartwell RX, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chartwell RX, LLC 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 62135-0712-42 · Chartwell 62135-0714-12 · Chartwell →
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.