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Dalfampridine 10 mg Tablet, Film Coated, Extended Release, 60-count

by Bryant Ranch Prepack · 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9450-1)
NDC 63629-9450-01
🏷️ FDA NDC (as labeled) 63629-9450-1 billing pads the package segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 63629-9450-1
Product NDC 63629-9450
11-digit billing NDC 63629945001
NCPDP billing unit EA — each (per item)
RxCUI 897021
UNII BH3B64OKL9
Application # ANDA206765
SPL Set ID b9ad68e2-a515-4dba-915d-401c555a8a26
Established class (EPC) Potassium Channel Blocker
Mechanism of action Potassium Channel Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2018-07-31
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance DALFAMPRIDINE
GCN Seq No 066066
GCN 28246
HICL code 013907
Ingredient (HICL) Dalfampridine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0F
Therapeutic class — specific (HIC3) Agts Tx Neuromusc Transmission Dis,Pot-Chan Blkr
AHFS code 92:56.00.00
AHFS class Protective Agents
FDB label name DALFAMPRIDINE ER 10 MG TABLET
FDB brand name Dalfampridine Er
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63629-9450-1 — a 5-4-1 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 package segment → 63629-9450-01. 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 Potassium Channel Blocker class.

Pharmacologic class Potassium Channel Blocker
Drug family (ATC) Other nervous system drugs
How it works Potassium Channel Antagonists
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

LabelerBryant Ranch Prepack
Application holderALKEM LABORATORIES LTD
FDA applicationANDA206765 (ANDA)
Labeler code63629
First marketedJul 2018
Product typeHuman Prescription Drug
Portfolio4,434 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 DALFAMPRIDINE ER 10 MG TABLET Ingredient Dalfampridine
📖 What it is MedlinePlus · NLM

Dalfampridine is used to improve walking in people who have multiple sclerosis (MS; a disease in which the nerves do not function properly and may cause weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Dalfampridine may be used alone or with other medications that control the symptoms of MS. Dalfampridine is in a class of medications called potassium channel blockers. It works by strengthening the signals sent by the brain through nerves that have been damaged by MS.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Dalfampridine is designed specifically to improve walking in adults with MS. It works by helping electrical signals travel more effectively through nerve fibers that have been dama...
  • What exactly does dalfampridine do — will it help me walk better?
  • You take one tablet twice a day, spacing your doses roughly 12 hours apart — for example, morning and evening. Food doesn't really matter; you can take it with or without a meal. T...
  • How do I take it — does it matter if I eat first?
📖 Read our full Dalfampridine 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer 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 · Q2 2026 $2.60 $155.77 / 60 tablets
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
Dalfampridine 10 mg 62756-0429-86 Sun 60 tablets $0.396 — FDA listed —
Dalfampridine 10 mg 00591-2533-60 Actavis 60 tablets $0.441 AB Availability likely —
Dalfampridine 10 mg 16729-0292-12 Accord 60 tablets $0.441 AB Availability likely —
Dalfampridine 10 mg 82249-0702-60 CivicaScript 60 tablets $0.441 AB Availability likely —
Ampyra 10 mg 00259-5010-60 Merz 60 tablets — AB FDA listed —
Ampyra 10 mg 10144-0427-60 Merz 60 tablets — AB FDA listed —
Dalfampridine 10 mg 42571-0275-05 Micro 500 tablets — AB FDA listed —
Dalfampridine 10 mg 51407-0876-60 Golden 60 tablets — AB FDA listed —
Dalfampridine 10 mgthis 63629-9450-01 Bryant 60 tablets — AB Discontinued —
Dalfampridine 10 mg 65862-0863-01 Aurobindo 100 tablets — AB FDA listed —
Dalfampridine 10 mg 67877-0444-05 Ascend 500 tablets — AB FDA listed —
Dalfampridine 10 mg 72162-2459-06 Bryant 60 tablets — AB 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

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

Medicare Part D (outpatient prescription) spending for Ampyra (matched by generic name) — 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 Ampyra. CMS lists 2 products for this generic; we show the highest-spend one. 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
$8.79M
Claims incl. refills
1.5K
Beneficiaries
710
Spend / beneficiary
$12,378.64
Spend / claim
$5,999.20
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.

🔬 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 DALFAMPRIDINE — the ingredient across all brands.

Top reported reactions

Gait Disturbance10,977
Fall7,335
Fatigue5,527
Balance Disorder4,900
Multiple Sclerosis Relapse4,774
Therapy Cessation4,510
Dizziness3,989

Age at onset

Infant1
Child2
Adolescent1
Adult2,104
Elderly390

Reporter sex

71,315 reports
Male · 26%
Female · 74%
Unknown · 1%

Serious outcomes

Hospitalization10,146
Death1,759
Disabling1,460
Life-threatening267
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,166 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
63629-9450-01 You're viewing this 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9450-1) 2022-09-28 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 63629-9450-1, 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: 63629-9450-01, written without dashes as 63629945001. 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 63629-9450-01, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (9450) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.

📄 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 67 words ▾

1 INDICATIONS AND USAGE Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14) ]. Dalfampridine is a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed ( 1 , 14 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The maximum recommended dosage is 10 mg twice daily (approximately 12 hours apart). There is no evidence of additional benefit with doses greater than 10 mg twice daily. Adverse reactions, including seizures, were more frequent at higher doses.

(2.1) Take with or without food. Administer tablets whole; do not divide, crush, chew, or dissolve (2.2) Patients should not take double or extra doses if they miss a dose. (2.2) Estimated creatinine clearance (CrCl) should be known before initiating treatment with dalfampridine extended-release tablets.

In patients with mild renal impairment (CrCl 51 to 80 mL/min), dalfampridine extended-release tablets may reach plasma levels associated with a greater risk of seizures, and the potential benefits of dalfampridine extended-release tablets should be carefully considered against the risk of seizures in these patients (2.3, 5.2, 8.6)

2.1Dosage Information The maximum recommended dosage of dalfampridine extended-release tablet is one 10 mg tablet twice daily and should not be exceeded. Take doses approximately 12 hours apart. There is no evidence of additional benefit at doses greater than 10 mg twice daily. Adverse reactions, including seizures, and discontinuations because of adverse reactions were more frequent at higher doses.

2.2Administration Instructions Dalfampridine extended-release tablet can be taken with or without food. Administer tablets whole; do not divide, crush, chew, or dissolve dalfampridine extended-release tablets. If a dose is missed, patients should not take double or extra doses.

2.3Renal Monitoring Prior to and During Treatment Estimated creatinine clearance (CrCl) should be known before initiating treatment with dalfampridine extended-release tablets, and monitored at least annually during treatment with dalfampridine extended-release tablets. CrCl can be estimated using the following equation (multiply by 0.85 for women):

2.4Dosage in Patients with Renal Impairment In patients with mild renal impairment (CrCl 51 to 80 mL/min), dalfampridine extended-release tablet plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that is 1.5 times the maximum recommended dose and may be associated with an increased risk of seizures. As mild renal impairment is common after age 50, estimating CrCl is particularly important in these patients. The potential benefits of dalfampridine extended-release tablet should be carefully considered against the risk of seizures in these patients [see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology (12.3)].

Dalfampridine extended-release tablet is contraindicated in patients with moderate or severe renal impairment (CrCl≤50 mL/min).

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Dalfampridine extended-release tablets are available in a 10 mg strength and is a white to off white, biconvex, oval shaped, beveled edge, film coated tablets, debossed “D 10” on one side and plain on other side. 10 mg tablets ( 3 )

⛔ Contraindications 74 words ▾

4 CONTRAINDICATIONS The use of dalfampridine extended-release tablets are contraindicated in the following conditions: History of seizure [see Warnings and Precautions (5.1)] Moderate or severe renal impairment (CrCl≤50 mL/min) [see Warnings and Precautions (5.2)] History of hypersensitivity to dalfampridine extended-release tablets or 4-aminopyridine; reactions have included anaphylaxis [see Warnings and Precautions (5.4)] History of seizure (4) Moderate or severe renal impairment (CrCl≤50 mL/min) (4) History of hypersensitivity to dalfampridine extended-release tablets or 4-aminopyridine (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Dalfampridine extended-release tablets can cause seizures; the risk of seizures increases with increasing dalfampridine extended-release tablets doses; discontinue dalfampridine extended-release tablets and do not restart if a seizure occurs (5.1) Avoid concomitant use with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same ( 5.3 ) Dalfampridine extended-release tablets can cause anaphylaxis. Discontinue and do not restart dalfampridine extended-release tablets if this occurs (5.4)

5.1Seizures Dalfampridine extended-release tablets can cause seizures. Increased incidence of seizures has been observed at 20 mg twice daily (2 times the maximum recommended dosage) in controlled clinical studies of 9 to 14 weeks duration with dalfampridine in patients with MS. In open-label extension trials in MS patients, the incidence of seizures during treatment with dalfampridine 15 mg twice daily (1.7/100PY) was over 4 times higher than the incidence during treatment with 10 mg twice daily (0.4/100PY).

In the post-marketing period seizures have been reported. The majority of seizures occurred at the recommended dose and in patients without a history of seizures, and generally within days to weeks of starting therapy. Dalfampridine extended-release tablets has not been evaluated in patients with a history of seizures or with evidence of epileptiform activity on an EEG, as these patients were excluded from clinical trials.

The risk of seizures in patients with epileptiform activity on an EEG is unknown, and could be substantially higher than that observed in dalfampridine extended-release tablets clinical studies. Permanently discontinue dalfampridine extended-release tablets in patients who have a seizure while on treatment. Dalfampridine extended-release tablets are contraindicated in patients with a history of seizures [see Contraindications (4)] .

5.2Renal Impairment Dalfampridine extended-release tablets are eliminated through the kidneys primarily as unchanged drug [see Clinical Pharmacology (12.3)]. Because patients with moderate to severe renal impairment (CrCl ≤50mL/min) would require a dose lower than 10 mg twice daily and no strength smaller than 10 mg is available, dalfampridine extended-release tablets are contraindicated in these patients [see Contraindications (4)]. In patients with mild renal impairment (CrCl 51 to 80 mL/min), dalfampridine extended-release tablets plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures [see Warnings and Precautions (5.1)].

5.3Concurrent Treatment with Other Forms of 4-Aminopyridine Avoid concomitant use with other forms of 4-aminopyridine (4-AP, fampridine) since the active ingredient is the same. Instruct patients to discontinue use of any product containing 4-aminopyridine prior to initiating treatment with dalfampridine extended-release tablets in order to reduce the potential for dose-related adverse reactions.

5.4Anaphylaxis Dalfampridine extended-release tablets can cause anaphylaxis and severe allergic reactions. Signs and symptoms have included respiratory compromise, urticaria, and angioedema of the throat and or tongue. Dalfampridine extended-release tablets are contraindicated in patients with a history of hypersensitivity to dalfampridine extended-release tablets or 4-aminopyridine.

Inform patients of the signs and symptoms of anaphylaxis and instruct them to discontinue dalfampridine extended-release tablets and seek immediate medical care should these signs and symptoms occur.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described in more detail elsewhere in the labeling: •Seizures [see Warnings and Precautions ( 5.1 )] •Anaphylaxis [see Warnings and Precautions ( 5.4 )] The most common adverse events (incidence ≥2% and at a rate greater than the placebo rate) for dalfampridine extended-release tablets were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In three placebo-controlled clinical trials of up to 14 weeks duration, 4% (15/400) of patients treated with dalfampridine extended-release tablets 10 mg twice daily experienced one or more adverse reactions leading to discontinuation, compared to 2% (5/238) of placebo-treated patients.

The adverse reactions leading to discontinuation of at least 2 patients treated with dalfampridine extended-release tablets and that led to discontinuation more frequently compared to placebo were headache (dalfampridine extended-release tablets 0.5%, placebo 0%), balance disorder (dalfampridine extended-release tablets 0.5%, placebo 0%), dizziness (dalfampridine extended-release tablets 0.5%, placebo 0%), and confusional state (dalfampridine extended-release tablets 0.3%, placebo 0%). Table 1 lists adverse reactions that occurred in ≥2% of patients treated with dalfampridine extended-release tablets 10 mg twice daily, and more frequently than in placebo-treated patients, in controlled clinical trials.

Table 1: Adverse Reactions with an Incidence ≥2% of dalfampridine extended-release tablets-Treated Adult MS Patients and More Frequent with dalfampridine extended-release tablets Compared to Placebo in Controlled Clinical Trials Adverse Reaction Placebo (N=238) % Dalfampridine extended-release tablets 10 mg twice daily (N=400) % Urinary tract infection 8 12 Insomnia 4 9 Dizziness 4 7 Headache 4 7 Nausea 3 7 Asthenia 4 7 Back pain 2 5 Balance disorder 1 5 Multiple sclerosis relapse 3 4 Paresthesia 3 4 Nasopharyngitis 2 4 Constipation 2 3 Dyspepsia 1 2 Pharyngolaryngeal pain 1 2 Other Adverse Reactions Dalfampridine extended-release tablets has been evaluated in a total of 1,952 subjects, including 917 MS patients.

A total of 741 patients have been treated with dalfampridine extended-release tablets for over six months, 501 for over one year and 352 for over two years. The experience in open-label clinical trials is consistent with the safety profile observed in the placebo-controlled clinical trials. As in controlled clinical trials, a dose-dependent increase in the incidence of seizures has been observed in open-label clinical trials with dalfampridine extended-release tablets in patients with MS as follows: Dalfampridine extended-release tablets 10 mg twice daily 0.41 per 100 person-years (95% confidence interval 0.13 to 0.96); dalfampridine 15 mg twice daily 1.7 per 100 person-years (95% confidence interval 0.21 to 6.28).

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use with dalfampridine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: vomiting, vertigo.

🔄 Drug Interactions 102 words ▾

7 DRUG INTERACTIONS OCT2 Inhibitors: Concomitant use may cause an increased exposure and potential risk of seizures ( 7.1 )

7.1OCT2 Inhibitors Concurrent treatment with OCT2 inhibitors, such as cimetidine, may cause increased exposure to dalfampridine [see Clinical Pharmacology ( 12.3 )] . Elevated levels of dalfampridine increase the risk of seizures [see Warnings and Precautions ( 5.1 , 5.2 )]. The potential benefits of taking OCT2 inhibitors concurrently with dalfampridine extended-release tablets should be considered against the risk of seizures in these patients.

7.2Baclofen No interaction was identified between dalfampridine and baclofen [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1) Geriatric use: Because elderly patients are more likely to have decreased renal function, it is particularly important to know the estimated CrCl in these patients before initiating dalfampridine extended-release tablets treatment ( 4 , 5.2 , 8.6 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of dalfampridine extended-release tablets in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of dalfampridine to pregnant rats and rabbits throughout organogenesis resulted in no evidence of developmental toxicity in either species. The highest doses tested (10 mg/kg/day in rats, 5mg/kg/day in rabbits), which were associated with maternal toxicity, are approximately 5 times the MRHD on a body surface area (mg/m 2 ) basis.

Oral administration of dalfampridine (0, 1, 3, and 9 to 6 mg/kg/day; high dose reduced during the second week of dosing) to female rats throughout pregnancy and lactation resulted in decreased offspring viability at the highest dose tested and decreased body weight in offspring at the mid and high doses. The no-effect dose for pre- and postnatal developmental toxicity in rats (1 mg/kg/day) is less than the MRHD on a mg/m 2 basis.

8.2Lactation Risk Summary There are no data on the presence of dalfampridine in human milk, the effects of dalfampridine on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dalfampridine extended-release tablets and any potential adverse effects on the breastfed infant from dalfampridine extended-release tablets or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in patients younger than 18 years of age have not been established.

8.5Geriatric Use Clinical studies of dalfampridine extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. A population PK analysis showed that dalfampridine clearance modestly decreased with increasing age, but not sufficiently to necessitate a modification of dose with age. Other reported clinical experience has identified no differences in responses between the elderly and younger patients.

Dalfampridine extended-release tablets are known to be substantially excreted by the kidneys and the risk of adverse reactions, including seizures, is greater with increasing exposure of dalfampridine. Because elderly patients are more likely to have decreased renal function, it is particularly important to know the estimated creatinine clearance (CrCl) in these patients [see Warnings and Precautions (5.2)].

8.6Impaired Renal Function Clearance of dalfampridine is decreased in patients with renal impairment and is significantly correlated with creatinine clearance (CrCl) [see Clinical Pharmacology (12.3)]. Dalfampridine extended-release tablets are contraindicated in patients with moderate or severe renal impairment (CrCl ≤50 mL/min) [see Contraindications ( 4 )]. The risk of seizures in patients with mild renal impairment (CrCl 51 to 80 mL/min) is unknown, but dalfampridine plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures.

If unknown, estimated creatinine clearance should be calculated prior to initiating treatment with dalfampridine…

🤰 Pregnancy 217 words ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of dalfampridine extended-release tablets in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of dalfampridine to pregnant rats and rabbits throughout organogenesis resulted in no evidence of developmental toxicity in either species. The highest doses tested (10 mg/kg/day in rats, 5mg/kg/day in rabbits), which were associated with maternal toxicity, are approximately 5 times the MRHD on a body surface area (mg/m 2 ) basis.

Oral administration of dalfampridine (0, 1, 3, and 9 to 6 mg/kg/day; high dose reduced during the second week of dosing) to female rats throughout pregnancy and lactation resulted in decreased offspring viability at the highest dose tested and decreased body weight in offspring at the mid and high doses. The no-effect dose for pre- and postnatal developmental toxicity in rats (1 mg/kg/day) is less than the MRHD on a mg/m 2 basis.

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and effectiveness in patients younger than 18 years of age have not been established.

🧓 Geriatric Use 126 words ▾

8.5Geriatric Use Clinical studies of dalfampridine extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. A population PK analysis showed that dalfampridine clearance modestly decreased with increasing age, but not sufficiently to necessitate a modification of dose with age. Other reported clinical experience has identified no differences in responses between the elderly and younger patients.

Dalfampridine extended-release tablets are known to be substantially excreted by the kidneys and the risk of adverse reactions, including seizures, is greater with increasing exposure of dalfampridine. Because elderly patients are more likely to have decreased renal function, it is particularly important to know the estimated creatinine clearance (CrCl) in these patients [see Warnings and Precautions (5.2)].

🆘 Overdosage 210 words ▾

10 OVERDOSAGE Three cases of overdose were reported in controlled clinical trials with dalfampridine extended-release tablets, involving two MS patients. The first patient took six times the currently recommended dose (60 mg) and was taken to the emergency room with altered mental state. The second patient took 40 mg doses on two separate occasions.

In the first instance, she experienced a complex partial seizure and, in the second instance, a period of confusion. Both patients recovered by the following day without sequelae. Several cases of overdose are found in the scientific literature in which various formulations of dalfampridine were used, resulting in numerous adverse events including seizure, confusion, tremulousness, diaphoresis, and amnesia.

In some instances, patients developed status epilepticus, requiring intensive supportive care and were responsive to standard therapy for seizures. In one published case report, an MS patient who ingested 300 mg of 4-aminopyridine (dalfampridine) developed a condition that resembled limbic encephalitis. This patient developed weakness, reduced awareness, memory loss, hypophonic speech, and temporal lobe hyperintensities on MRI.

The patient’s speech and language and ambulation improved over time, and an MRI at 4 months after the overdose no longer showed signal abnormalities. At one year, the patient continued to have difficulty with short term memory and learning new tasks.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of action The mechanism by which dalfampridine exerts its therapeutic effect has not been fully elucidated. Dalfampridine is a broad spectrum potassium channel blocker. In animal studies, dalfampridine has been shown to increase conduction of action potentials in demyelinated axons through inhibition of potassium channels.

12.2Pharmacodynamics Dalfampridine extended-release tablets does not prolong the QTc interval and does not have a clinically important effect on QRS duration.

12.3Pharmacokinetics Absorption and Distribution Orally administered dalfampridine is rapidly and completely absorbed from the gastrointestinal tract. Absolute bioavailability of dalfampridine extended-release tablets has not been assessed, but relative bioavailability is 96% when compared to an aqueous oral solution. The extended release tablet delays absorption of dalfampridine relative to the solution formulation, giving a slower rise to a lower peak concentration (C max ), with no effect on the extent of absorption (AUC).

Single dalfampridine extended-release tablet 10 mg doses administered to healthy volunteers in a fasted state gave peak concentrations ranging from 17.3 ng/mL to 21.6 ng/mL occurring 3 to 4 hours post-administration (T max ). In comparison, C max with the same 10 mg dose of dalfampridine in an oral solution was 42.7 ng/mL and occurred approximately 1.3 hours after dosing. Exposure increased proportionally with dose.

Dalfampridine is largely unbound to plasma proteins (97 to 99%). The apparent volume of distribution is

2.6L/kg. There is no apparent difference in pharmacokinetic parameter values following administration of dalfampridine extended-release tablets to either healthy volunteers or patients with MS. When dalfampridine is taken with food, there is a slight increase in C max (12 to 17%) and a slight decrease in AUC (4 to 7%).

These changes in exposure are not clinically significant, and therefore the drug may be taken with or without food [see Dosage and Administration (2.2) ]. Metabolism and Elimination Dalfampridine and metabolites elimination is nearly complete after 24 hours, with 95.9% of the dose recovered in urine and 0.5% recovered in feces. Most of the excreted radioactivity in urine was parent drug (90.3%).

Two metabolites were identified: 3-hydroxy-4-aminopyridine (4.3%) and 3-hydroxy-4-aminopyridine sulfate (2.6%). These metabolites have been shown to have no pharmacologic activity on potassium channels. The apparent elimination half-life of dalfampridine following administration of the extended release tablet formulation of dalfampridine is 5.2 to 6.5 hours.

The plasma half-life of the sulfate conjugate is approximately 7.6 hours and the half-life of 3-hydroxy-4-aminopyridine could not be calculated because concentrations for most subjects were close to or below the limit of quantitation. In vitro studies with human liver microsomes indicate that CYP2E1 was the major enzyme responsible for the 3-hydroxylation of dalfampridine. The identity of the CYP enzymes suspected of playing a minor role in the 3-hydroxylation of dalfampridine could not be established unequivocally.

Specific Populations Pediatric The safety and effectiveness in patients younger than 18 years of age have not been established. Geriatric A population pharmacokinetic analysis showed that dalfampridine clearance modestly decreased with increasing age, but not sufficiently to necessitate a modification of dose. Gender A population pharmacokinetic analysis suggested that female patients would be expected to have higher maximum dalfampridine plasma concentration than male patients.

The magnitude of these differences is small and does not necessitate any dose modification. Renal Impairment [see Contraindications (4) and Warnings and Precautions (5.2)]. The pharmacokinetics of dalfampridine was studied in 9 male and 11 female subjects with varying degrees of renal function.

Elimination of the drug is signifi…

🧬 Mechanism of Action 47 words ▾

12.1Mechanism of action The mechanism by which dalfampridine exerts its therapeutic effect has not been fully elucidated. Dalfampridine is a broad spectrum potassium channel blocker. In animal studies, dalfampridine has been shown to increase conduction of action potentials in demyelinated axons through inhibition of potassium channels.

📦 How Supplied / Storage and Handling 58 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dalfampridine extended-release tablets, 10 mg are white to off white, biconvex, oval shaped, beveled edge, film coated tablets, debossed “D 10” on one side and plain on other side. NDC 63629-9450-01 bottles of 60 tablets Store at 25°C (77°F); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].

📋 Description 144 words ▾

11 DESCRIPTION Dalfampridine is a potassium channel blocker, available in a 10 mg tablet strength. Each tablet contains 10 mg dalfampridine, formulated as an extended-release tablet for twice-daily oral administration. Dalfampridine is also known by its chemical name, 4-aminopyridine, with the following structure: Dalfampridine extended-release tablets are available in a 10 mg strength and are white to off white, biconvex, oval shaped, beveled edge, film coated tablets, debossed “D 10” on one side and plain on other side, containing 10 mg of dalfampridine.

Inactive ingredients consist of colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Dalfampridine is a White to off white crystalline powder with a molecular weight of 94.1, CAS 504-24-5, and a molecular formula of C 5 H 6 N 2 . At ambient conditions, dalfampridine is soluble in water, methanol, acetone, isopropanol, acetonitrile and N,N-dimethylformamide.

💬 Information for Patients 212 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risk of Seizures Inform patients that dalfampridine extended-release tablets can cause seizures, and that they must discontinue use of dalfampridine extended-release tablets if they experience a seizure [see Warnings and Precautions (5.1)]. Dalfampridine extended-release tablets dosing Instruct patients to take dalfampridine extended-release tablets exactly as prescribed.

Instruct patients not to take a double dose after they miss a dose, as this would increase their risk of seizure. Instruct patients not to take more than 2 tablets in a 24-hour period and to make sure that there is an approximate 12-hour interval between doses [see Dosage and Administration (2.1, 2.2)]. Anaphylaxis Advise patients to discontinue dalfampridine extended-release tablets and seek medical care if they develop signs and symptoms of anaphylaxis [see Warnings and Precautions (5.4)].

Drug Interactions Instruct patients to notify their healthcare provider prior to starting any new medication, including over-the-counter drugs. Storage Advise patients to store dalfampridine extended-release tablets at 25°C (77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Advise patients to safely throw away dalfampridine extended-release tablets that are out of date or no longer needed.

Manufactured by: Alkem LaboratoriesLtd., INDIA. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: November, 2021

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Dalfampridine extended-release tablets (dal FAM pri dine) Read this Medication Guide before you start taking dalfampridine extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about dalfampridine extended-release tablets? Dalfampridine extended-release tablets can cause seizures. You could have a seizure even if you never had a seizure before.

Your chance of having a seizure is higher if you take too much dalfampridine extended-release tablets or if your kidneys have a mild decrease of function, which is common after age 50. Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking dalfampridine extended-release tablets. Do not take dalfampridine extended-release tablets if you have ever had a seizure.

Before taking dalfampridine extended-release tablets tell your doctor if you have kidney problems. Take dalfampridine extended-release tablets exactly as prescribed by your doctor. See “How should I take dalfampridine extended-release tablets?” Stop taking dalfampridine extended-release tablets and call your doctor right away if you have a seizure while taking dalfampridine extended-release tablets.

What is dalfampridine extended-release tablets? Dalfampridine extended-release tablet is a prescription medicine used to help improve walking in adults with multiple sclerosis (MS). This was shown by an increase in walking speed.

It is not known if dalfampridine extended-release tablets are safe or effective in children less than 18 years of age. Who should not take dalfampridine extended-release tablets? Do not take dalfampridine extended-release tablets if you: have ever had a seizure have certain types of kidney problems are allergic to dalfampridine (4-aminopyridine), the active ingredient in dalfampridine extended-release tablets What should I tell my doctor before taking dalfampridine extended-release tablets?

Before you take dalfampridine extended-release tablets, tell your doctor if you: have any other medical conditions are taking compounded 4-aminopyridine (fampridine, 4-AP) are taking any other medicines, including over-the-counter medicines such as cimetidine are pregnant or plan to become pregnant. It is not known if dalfampridine extended-release tablets will harm your unborn baby. are breast-feeding or plan to breast-feed. It is not known if dalfampridine extended-release tablets passes into your breast milk.

Talk with your healthcare provider about the best way to feed your baby if you take dalfampridine extended-release tablets. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Know the medicines you take.

Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. How should I take dalfampridine extended-release tablets? Take dalfampridine extended-release tablets exactly as your doctor tells you to take it.

Do not change your dose of dalfampridine extended-release tablets. Take one tablet of dalfampridine extended-release tablets 2 times each day about 12 hours apart. Do not take more than 2 dalfampridine extended-release tablets in a 24-hour period.

Take dalfampridine extended-release tablets whole. Do not break, crush, chew or dissolve dalfampridine extended-release tablets before swallowing. If you cannot swallow dalfampridine extended-release tablets whole, tell your doctor.

Dalfampridine extended-release tablets are released slowly over time. If the tablet is broken, the medicine may be released too fast. This can raise your chance of having a seizure.

Dalfampridine extended-release tablets can be taken with or without food. If you miss a dose of dalfampridine extended-release tablets, do not make up the missed do…

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