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VIGADRONE vigabatrin 50 mg/mL Powder, For Solution — NDC 00245-0556-50 package photo
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VIGADRONE vigabatrin 50 mg/mL Powder, For Solution — NDC 0245-0556-50 (Billing 00245-0556-50)

by Upsher-Smith Laboratories, LLC · 50 PACKET in 1 CARTON / 10 mL in 1 PACKET

This is a package of VIGADRONE vigabatrin 50 mg/mL Powder, For Solution from Upsher-Smith Laboratories, LLC, marketed since Jun 2018 and currently FDA-listed. It is this product's only package size.

NDC 00245-0556-50
🏷️ FDA NDC (as labeled) 0245-0556-50 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled 🛡 REMS ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0245-0556-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0245 labeler · 0556 product · 50 package
Package marketed since
Jun 21, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0245055650 3
Medicaid fills, this package
5,387 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0245-0556-50
Product NDC 0245-0556
11-digit billing NDC 00245055650
NCPDP billing unit EA — each (per item)
RxCUI 250820, 2047868
UNII GR120KRT6K
Application # ANDA210196
SPL Set ID 5e5e7554-d0f4-47f7-a434-cc5ca5a9826f
Established class (EPC) Anti-epileptic Agent
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-06-21
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance VIGABATRIN
TE code (Orange Book) AA · RLD · RS

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

GPI-14 72170085003020
GPI class Vigadrone
GCN Seq No 017869
GCN 64314
HICL code 007377
Ingredient (HICL) Vigabatrin
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 28:12.28.00
AHFS class Gaba-Mediated Anticonvulsants
FDB label name VIGADRONE 500 MG POWDER PACKET
FDB brand name Vigadrone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 017869
  • GCN: 64314
  • GPI-14 (Medi-Span): 72170085003020
  • HICL (First Databank): 007377
  • AHFS class code: 28:12.28.00
  • RxCUI (RxNorm): 250820
Why two NDCs? The FDA registers this code as 0245-0556-50 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00245-0556-50. 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 Anti-epileptic Agent class.

Pharmacologic class Anti-epileptic Agent
Drug family (ATC) Fatty acid derivatives
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 VIGADRONE 500 MG POWDER PACKET Ingredient Vigabatrin
📖 What it is MedlinePlus · NLM

Vigabatrin is used in combination with other medications to control certain types of seizures in adults and children 2 years of age or older whose seizures were not controlled by several other medications. Vigabatrin is also used to control infantile spasms (a type of seizure that babies and children can have) in babies 1 month to 2 years of age. Vigabatrin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats infantile spasms in babies 1 month to 2 years old. It is also an add-on for complex partial seizures in people 2 and older when other medicines haven't worked well enough...
  • Vigabatrin can cause permanent vision loss, and you may not notice it until it's severe. Eye tests are recommended at the start, at least every 3 months, and after stopping. They h...
  • It's taken by mouth, usually twice a day, as a tablet or liquid. Food doesn't change how much you absorb. Follow your prescriber's directions and don't stop it suddenly, as that co...
  • Sleepiness, tiredness, dizziness, headache, tremor, blurred vision and weight gain are common. Infants may get more colds and ear infections. Call me or your doctor about any visio...
📖 Read our full Vigabatrin guide →
1
Nutrient depletion considerations

Vigabatrin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Vigabatrin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $91.08 $45,540.10 / 500 ml
Medicare drug plans payPart D · Q2 2026 $86.68 $43,340.75 / 500 ml
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
00245-0556-50 You're viewing this Main listing 50 PACKET in 1 CARTON / 10 mL in 1 PACKET 2018-06-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vigadrone 50 mg/mLthis 00245-0556-50 Upsher-Smith 50 packets — AA FDA listed —
vigabatrin for oral solution 50 mg/mL 31722-0009-50 Camber 50 packets — AA FDA listed —
Vigabatrin 50 mg/mL 43598-0697-50 Dr. 50 packets — AA FDA listed —
Vigabatrin 50 mg/mL 49884-0358-03 Par 50 packets — AA FDA listed —
Vigabatrin 500 mg 59651-0366-50 Aurobindo 50 packets — AA FDA listed —
Vigabatrin 500 mg 60219-1425-05 Amneal 50 fors — AA FDA listed —
Sabril 50 mg/mL 67386-0211-65 Lundbeck 50 packets — AA FDA listed —
Vigabatrin 50 mg/mL 67877-0674-63 Ascend 50 packets — AA FDA listed —
Vigabatrin 500 mg/mL 69097-0964-53 Cipla 50 packets — AA FDA listed —
Vigabatrin 500 mg 69238-1425-05 Amneal 50 fors — AA FDA listed —
vigabatrin 500 mg/10mL 70710-1494-08 Zydus 50 packets — — FDA listed —
vigabatrin 500 mg/10mL 70771-1742-08 Zydus 50 packets — — FDA listed —
Vigabatrin 50 mg/mL 72205-0093-50 Novadoz 50 packets — 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

🏛️
2018
On the market since
Jun 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.

What it looks like

Color white
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.

🧪 Avoiding an ingredient? See Vigabatrin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

Manufacturer & labeler

LabelerUpsher-Smith Laboratories, LLC
Application holderBORA PHARMACEUTICAL HOLDINGS LLC
FDA applicationANDA210196 (ANDA)
Labeler code00245
First marketedJun 2018
Product typeHuman Prescription Drug
Portfolio229 products on file

More NDCs from Upsher-Smith Laboratories, LLC labeler code 00245

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: PERMANENT VISION LOSS VIGADRONE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGADRONE also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The onset of vision loss from VIGADRONE is unpredictable and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years.

Symptoms of vision loss from VIGADRONE are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function. The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.

Vision assessment is recommended at baseline (no later than 4 weeks after starting VIGADRONE), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy. Once detected, vision loss due to VIGADRONE is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss.

Consider drug discontinuation, balancing benefit and risk, if vision loss is documented. Risk of new or worsening vision loss continues as long as VIGADRONE is used. It is possible that vision loss can worsen despite discontinuation of VIGADRONE.

Because of the risk of vision loss, VIGADRONE should be withdrawn from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2 to 4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious. Patient response to and continued need for VIGADRONE should be periodically reassessed. VIGADRONE should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks.

VIGADRONE should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks. Use the lowest dosage and shortest exposure to VIGADRONE consistent with clinical objectives [see Dosage and Administration ( 2.1 )]. Because of the risk of permanent vision loss, VIGADRONE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Vigabatrin REMS Program [see Warnings and Precautions ( 5.2 ) ].

Further information is available at www.vigabatrinREMS.com or call 1 -866-244-8175. WARNING: PERMANENT VISION LOSS See full prescribing information for complete boxed warning. VIGADRONE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability.

In some cases, VIGADRONE may also decrease visual acuity ( 5.1 ). Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to VIGADRONE known to be free of risk of vision loss ( 5.1 ). Risk of new and worsening vision loss continues as long as VIGADRONE is used, and possibly after discontinuing VIGADRONE ( 5.1 ).

Baseline and periodic vision assessment is recommended for patients on VIGADRONE. However, this assessment cannot always prevent vision damage ( 5.1 ). VIGADRONE is available only through a restricted program called the Vigabatrin REMS Program ( 5.2 ).

🎯 Indications and Usage 184 words ▾

1 INDICATIONS AND USAGE VIGADRONE is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; VIGADRONE is not indicated as a first line agent ( 1.1 ) Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2 )

1.1Refractory Complex Partial Seizures (CPS) VIGADRONE is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions ( 5.1 )] . VIGADRONE is not indicated as a first line agent for complex partial seizures.

1.2Infantile Spasms (IS) VIGADRONE is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions ( 5.1 )].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Refractory Complex Partial Seizures Adults (17 years of age and older): Initiate at 1000 mg/day (500 mg twice daily); increase total daily dose weekly in 500 mg/day increments, to the recommended dose of 3000 mg/day (1500 mg twice daily) ( 2.2 ) Pediatric (2 to 16 years of age): The recommended dosage is based on body weight and administered as two divided doses ( 2.2 ) The dosage may be increased in weekly intervals, depending on response ( 2.2 ) Dose patients weighing more than 60 kg according to adult recommendations ( 2.2 ) Infantile Spasms Initiate at a daily dose of 50 mg/kg (25 mg/kg twice daily); increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily) ( 2.3 ) Renal Impairment : Dose adjustment recommended ( 2.4 , 8.5 , 8.6 )

2.1Important Dosing and Administration Instructions Dosing Use the lowest dosage and shortest exposure to VIGADRONE consistent with clinical objectives [see Warnings and Precautions ( 5.1 )]. The VIGADRONE dosing regimen depends on the indication, age group, weight, and dosage form (tablets or for oral solution) [see Dosage and Administration ( 2.2 , 2.3 )] . Patients with impaired renal function require dose adjustment [see Dosage and Administration ( 2.4 )].

Monitoring of VIGADRONE plasma concentrations to optimize therapy is not helpful. Administration VIGADRONE is given orally with or without food. VIGADRONE for oral solution should be mixed with water prior to administration [see Dosage and Administration ( 2.5 )].

A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. If a decision is made to discontinue VIGADRONE, the dose should be gradually reduced [see Dosage and Administration ( 2.2 , 2.3 ) and Warnings and Precautions ( 5.6 )].

2.2Refractory Complex Partial Seizures Adults (Patients 17 Years of Age and Older) Treatment should be initiated at 1000 mg/day (500 mg twice daily). Total daily dose may be increased in 500 mg increments at weekly intervals, depending on response. The recommended dose of VIGADRONE in adults is 3000 mg/day (1500 mg twice daily).

A 6000 mg/day dose has not been shown to confer additional benefit compared to the 3000 mg/day dose and is associated with an increased incidence of adverse events. In controlled clinical studies in adults with complex partial seizures, vigabatrin was tapered by decreasing the daily dose 1000 mg/day on a weekly basis until discontinued [see Warnings and Precautions ( 5.6 )]. Pediatric (Patients 2 to 16 Years of Age) The recommended dosage is based on body weight and administered as two divided doses, as shown in Table 1.

The dosage may be increased in weekly intervals to the total daily maintenance dosage, depending on response. Pediatric patients weighing more than 60 kg should be dosed according to adult recommendations. Table 1.

CPS Dosing Recommendations for Pediatric Patients Weighing 10 kg up to 60 kg †† Body Weight [kg] Total Daily* Starting Dose [mg/day] Total Daily* Maintenance Dose † [mg/day] 10 kg to 15 kg 350 mg 1,050 mg Greater than 15 kg to 20 kg 450 mg 1,300 mg Greater than 20 kg to 25 kg 500 mg 1,500 mg Greater than 25 kg to 60 kg 500 mg 2,000 mg * Administered in two divided doses. † Maintenance dose is based on 3000 mg/day adult-equivalent dose †† Patients weighing more than 60 kg should be dosed according to adult recommendations In patients with refractory complex partial seizures, VIGADRONE should be withdrawn if a substantial clinical benefit is not observed within 3 months of initiating treatment.

If, in the clinical judgment of the prescriber, evidence of treatment failure becomes obvious earlier than 3 months, treatment should be discontinued at that time [see Warnings and Precautions ( 5.1 )] . In a controlled study in pediatric patients with complex partial seizures, vigabatr… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS For oral solution 500 mg packets containing a white to off-white granular powder. For Oral Solution: 500 mg per packet( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Abnormal MRI signal changes and intramyelinic edema have been reported in some infants with Infantile Spasms receiving vigabatrin ( 5.3 , 5.4 ) Suicidal behavior and ideation: Antiepileptic drugs, including VIGADRONE, increase the risk of suicidal thoughts and behavior ( 5.5 ) Withdrawal of AEDs: Taper dose to avoid withdrawal seizures ( 5.6 ) Anemia: Monitor for symptoms of anemia ( 5.7 ) Somnolence and fatigue: Advise patients not to drive or operate machinery until they have gained sufficient experience on VIGADRONE ( 5.8 )

5.1Permanent Vision Loss VIGADRONE can cause permanent vision loss. Because of this risk and because, when it is effective, VIGADRONE provides an observable symptomatic benefit; patient response and continued need for treatment should be periodically assessed. Based upon adult studies, 30 percent or more of patients can be affected with bilateral concentric visual field constriction ranging in severity from mild to severe.

Severe cases may be characterized by tunnel vision to within 10 degrees of visual fixation, which can result in disability. In some cases, VIGADRONE also can damage the central retina and may decrease visual acuity. Symptoms of vision loss from VIGADRONE are unlikely to be recognized by patients or caregivers before vision loss is severe.

Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function. Because assessing vision may be difficult in infants and children, the frequency and extent of vision loss is poorly characterized in these patients. For this reason, the understanding of the risk is primarily based on the adult experience.

The possibility that vision loss from VIGADRONE may be more common, more severe, or have more severe functional consequences in infants and children than in adults cannot be excluded. The onset of vision loss from VIGADRONE is unpredictable and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years. The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.

In patients with refractory complex partial seizures, VIGADRONE should be withdrawn if a substantial clinical benefit is not observed within 3 months of initiating treatment. If, in the clinical judgment of the prescriber, evidence of treatment failure becomes obvious earlier than 3 months, treatment should be discontinued at that time [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.6 )] . In patients with infantile spasms, VIGADRONE should be withdrawn if a substantial clinical benefit is not observed within 2 to 4 weeks.

If, in the clinical judgment of the prescriber, evidence of treatment failure becomes obvious earlier than 2 to 4 weeks, treatment should be discontinued at that time [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.6 )]. VIGADRONE should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks. The interaction of other types of irreversible vision damage with vision damage from VIGADRONE has not been well-characterized, but is likely adverse.

VIGADRONE should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks. Monitoring of Vision Monitoring of vision by an ophthalmic professional with expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina is recommended [see Warnings and Precautions ( 5.2 )]. Because vision testing in infants is difficult, vision loss may not be detected until it is severe.

For patients receiving VIGADRONE, vision assessment is recommended at baseline (no later than 4 weeks after starting VIGADRONE), at least every… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are described elsewhere in labeling: Permanent Vision Loss [see BOXED WARNING and Warnings and Precautions ( 5.1 )] Magnetic Resonance Imaging (MRI) Abnormalities in Infants [see Warnings and Precautions ( 5.3 )] Neurotoxicity [see Warnings and Precautions ( 5.4 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.5 )] Withdrawal of Antiepileptic Drugs (AEDs) [see Warnings and Precautions ( 5.6 )] Anemia [see Warnings and Precautions ( 5.7 )] Somnolence and Fatigue [see Warnings and Precautions ( 5.8 )] Peripheral Neuropathy [see Warnings and Precautions ( 5.9 )] Weight Gain [see Warnings and Precautions ( 5.10 )] Edema [see Warnings and Precautions ( 5.11 )] Refractory Complex Partial Seizures Most common adverse reactions in controlled studies include (incidence ≥5% over placebo): Adults: blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue ( 6.1 ) Pediatric patients (3 to 16 years of age): weight gain ( 6.1 ) Infantile Spasms (incidence ˃5% and greater than on placebo) Somnolence, bronchitis, ear infection, and acute otitis media ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In U.S. and primary non-U.S. clinical studies of 4,079 vigabatrin-treated patients, the most common (≥5%) adverse reactions associated with the use of vigabatrin in combination with other AEDs were headache, somnolence, fatigue, dizziness, convulsion, nasopharyngitis, weight gain, upper respiratory tract infection, visual field defect, depression, tremor, nystagmus, nausea, diarrhea, memory impairment, insomnia, irritability, abnormal coordination, blurred vision, diplopia, vomiting, influenza, pyrexia, and rash.

The adverse reactions most commonly associated with vigabatrin treatment discontinuation in ≥1% of patients were convulsion and depression. In patients with infantile spasms, the adverse reactions most commonly associated with vigabatrin treatment discontinuation in ≥1% of patients were infections, status epilepticus, developmental coordination disorder, dystonia, hypotonia, hypertonia, weight gain, and insomnia. Refractory Complex Partial Seizures Adults Table 5 lists the adverse reactions that occurred in ≥2% and more than one patient per vigabatrin-treated group and that occurred more frequently than in placebo patients from 2 U.S. adjunctive clinical studies of refractory CPS in adults.

Table 5. Adverse Reactions in Pooled, Adjunctive Trials in Adults withRefractory Complex Partial Seizures Vigabatrin dosage (mg/day) Body System Adverse Reaction 3,000 [N=134] % 6,000 [N=43] % Placebo [N=135] % Ear D i sorders Tinnitus 2 0 1 Vertigo 2 5 1 Eye Disorders Blurred vision 13 16 5 Diplopia 7 16 3 Asthenopia 2 2 0 Eye pain 0 5 0 Gastrointestinal Disorders Diarrhea 10 16 7 Nausea 10 2 8 Vomiting 7 9 6 Constipation 8 5 3 Upper abdominal pain 5 5 1 Dyspepsia 4 5 3 Stomach discomfort 4 2 1 Abdominal pain 3 2 1 Toothache 2 5 2 Abdominal distension 2 0 1 General Disorders Fatigue 23 40 16 Gait disturbance 6 12 7 Asthenia 5 7 1 Edema peripheral 5 7 1 Fever 4 7 3 Chest pain 1 5 1 Thirst 2 0 0 Malaise 0 5 0 Infections Nasopharyngitis 14 9 10 Upper respiratory tract infection 7 9 6 Influenza 5 7 4 Urinary tract infection 4 5 0 Bronchitis 0 5 1 Injury Contusion 3 5 2 Joint sprain 1 2 1 Muscle strain 1 2 1 Wound secretion 0 2 0 Metabolism and Nutrition Disorders Increased appetite 1 5 1 Weight gain 6 14 3 Musculoskeletal Disorders Arthralgia 10 5 3 Back pain 4 7 2 Pain in extremity 6 2 4 Myalgia 3 5 1 Muscle twitching 1 9 1 Muscle spasms 3… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Decreased phenytoin plasma levels: dosage adjustment may be needed ( 7.1 )

7.1Antiepileptic Drugs Phenytoin Although phenytoin dose adjustments are not routinely required, dose adjustment of phenytoin should be considered if clinically indicated, since VIGADRONE may cause a moderate reduction in total phenytoin plasma levels [see Clinical Pharmacology ( 12.3 )]. Clonazepam VIGADRONE may moderately increase the C max of clonazepam resulting in an increase of clonazepam-associated adverse reactions [see Clinical Pharmacology ( 12.3 )]. Other AEDs There are no clinically significant pharmacokinetic interactions between vigabatrin and either phenobarbital or sodium valproate.

Based on population pharmacokinetics, carbamazepine, clorazepate, primidone, and sodium valproate appear to have no effect on plasma concentrations of vigabatrin [see Clinical Pharmacology ( 12.3 )].

7.2Oral Contraceptives VIGADRONE is unlikely to affect the efficacy of steroid oral contraceptives [see Clinical Pharmacology ( 12.3 )].

7.3Drug-Laboratory Test Interactions VIGADRONE decreases alanine transaminase (ALT) and aspartate transaminase (AST) plasma activity in up to 90% of patients. In some patients, these enzymes become undetectable. The suppression of ALT and AST activity by VIGADRONE may preclude the use of these markers, especially ALT, to detect early hepatic injury.

VIGADRONE may increase the amount of amino acids in the urine, possibly leading to a false positive test for certain rare genetic metabolic diseases (e.g., alpha aminoadipic aciduria).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ) Lactation: VIGADRONE is excreted in human milk ( 8.2 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including VIGADRONE, during pregnancy. Encourage women who are taking VIGADRONE during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/.

This must be done by the patient herself. Risk Summary There are no adequate data on the developmental risk associated with the use of VIGADRONE in pregnant women. Limited available data from case reports and cohort studies pertaining to VIGADRONE use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

However, based on animal data, VIGADRONE use in pregnant women may result in fetal harm. When administered to pregnant animals, vigabatrin produced developmental toxicity, including an increase in fetal malformations and offspring neurobehavioral and neurohistopathological effects, at clinically relevant doses. In addition, developmental neurotoxicity was observed in rats treated with vigabatrin during a period of postnatal development corresponding to the third trimester of human pregnancy (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 Administration of vigabatrin (oral doses of 50 to 200 mg/kg/day) to pregnant rabbits throughout the period of organogenesis was associated with an increased incidence of malformations (cleft palate) and embryofetal death; these findings were observed in two separate studies.

The no-effect dose for adverse effects on embryofetal development in rabbits (100 mg/kg/day) is approximately ½ the maximum recommended human dose (MRHD) of 3 g/day on a body surface area (mg/m 2 ) basis. In rats, oral administration of vigabatrin (50, 100, or 150 mg/kg/day) throughout organogenesis resulted in decreased fetal body weights and increased incidences of fetal anatomic variations. The no-effect dose for adverse effects on embryo-fetal development in rats (50 mg/kg/day) is approximately 1 / 5 the MRHD on a mg/m 2 basis.

Oral administration of vigabatrin (50, 100, 150 mg/kg/day) to rats from the latter part of pregnancy through weaning produced long-term neurohistopathological (hippocampal vacuolation) and neurobehavioral (convulsions) abnormalities in the offspring. A no-effect dose for developmental neurotoxicity in rats was not established; the low-effect dose (50 mg/kg/day) is approximately 1 / 5 the MRHD on a mg/m 2 basis. In a published study, vigabatrin (300 or 450 mg/kg) was administered by intraperitoneal injection to a mutant mouse strain on a single day during organogenesis (day 7, 8, 9, 10, 11, or 12).

An increase in fetal malformations (including cleft palate) was observed at both doses. Oral administration of vigabatrin (5, 15, or 50 mg/kg/day) to young rats during the neonatal and juvenile periods of development (postnatal days 4 to 65) produced neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain vacuolation, decreased myelination, and retinal dysplasia) abnormalities in treated animals. The early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development.

The no-effect dose for developmental neurotoxicity in juvenile rats (5 mg/kg/day) was associated with plasma vigabatrin exposures (AUC) less than 1 / 30 of those measured in pediatric patients receiving an oral dose… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including VIGADRONE, during pregnancy. Encourage women who are taking VIGADRONE during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/.

This must be done by the patient herself. Risk Summary There are no adequate data on the developmental risk associated with the use of VIGADRONE in pregnant women. Limited available data from case reports and cohort studies pertaining to VIGADRONE use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

However, based on animal data, VIGADRONE use in pregnant women may result in fetal harm. When administered to pregnant animals, vigabatrin produced developmental toxicity, including an increase in fetal malformations and offspring neurobehavioral and neurohistopathological effects, at clinically relevant doses. In addition, developmental neurotoxicity was observed in rats treated with vigabatrin during a period of postnatal development corresponding to the third trimester of human pregnancy (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 Administration of vigabatrin (oral doses of 50 to 200 mg/kg/day) to pregnant rabbits throughout the period of organogenesis was associated with an increased incidence of malformations (cleft palate) and embryofetal death; these findings were observed in two separate studies.

The no-effect dose for adverse effects on embryofetal development in rabbits (100 mg/kg/day) is approximately ½ the maximum recommended human dose (MRHD) of 3 g/day on a body surface area (mg/m 2 ) basis. In rats, oral administration of vigabatrin (50, 100, or 150 mg/kg/day) throughout organogenesis resulted in decreased fetal body weights and increased incidences of fetal anatomic variations. The no-effect dose for adverse effects on embryo-fetal development in rats (50 mg/kg/day) is approximately 1 / 5 the MRHD on a mg/m 2 basis.

Oral administration of vigabatrin (50, 100, 150 mg/kg/day) to rats from the latter part of pregnancy through weaning produced long-term neurohistopathological (hippocampal vacuolation) and neurobehavioral (convulsions) abnormalities in the offspring. A no-effect dose for developmental neurotoxicity in rats was not established; the low-effect dose (50 mg/kg/day) is approximately 1 / 5 the MRHD on a mg/m 2 basis. In a published study, vigabatrin (300 or 450 mg/kg) was administered by intraperitoneal injection to a mutant mouse strain on a single day during organogenesis (day 7, 8, 9, 10, 11, or 12).

An increase in fetal malformations (including cleft palate) was observed at both doses. Oral administration of vigabatrin (5, 15, or 50 mg/kg/day) to young rats during the neonatal and juvenile periods of development (postnatal days 4 to 65) produced neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain vacuolation, decreased myelination, and retinal dysplasia) abnormalities in treated animals. The early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development.

The no-effect dose for developmental neurotoxicity in juvenile rats (5 mg/kg/day) was associated with plasma vigabatrin exposures (AUC) less than 1 / 30 of those measured in pediatric patients receiving an oral dose of 50 mg/kg.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of VIGADRONE as adjunctive treatment of refractory complex partial seizures in pediatric patients 2 to 16 years of age have been established and is supported by three double-blind, placebo-controlled studies in patients 3 to 16 years of age, adequate and well-controlled studies in adult patients, pharmacokinetic data from patients 2 years of age and older, and additional safety information in patients 2 years of age [ s ee Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.1 )].

The dosing recommendation in this population varies according to age group and is weight-based [see Dosage and Administration ( 2.2 )]. Adverse reactions in this pediatric population are similar to those observed in the adult population [see Adverse Reactions ( 6.1 )] . The safety and effectiveness of VIGADRONE as monotherapy for pediatric patients with infantile spasms (1 month to 2 years of age) have been established [see Dosage and Administration ( 2.3 ) and Clinical Studies ( 14.2 )] .

Safety and effectiveness as adjunctive treatment of refractory complex partial seizures in pediatric patients below the age of 2 and as monotherapy for the treatment of infantile spasms in pediatric patients below the age of 1 month have not been established. Duration of therapy for infantile spasms was evaluated in a post hoc analysis of a Canadian Pediatric Epilepsy Network (CPEN) study of developmental outcomes in infantile spasms patients. This analysis suggests that a total duration of 6 months of vigabatrin therapy is adequate for the treatment of infantile spasms.

However, prescribers must use their clinical judgment as to the most appropriate duration of use [ s ee Clinical Studies ( 14.2 )]. Abnormal MRI signal changes and Intramyelinic Edema (IME) in infants and young children being treated with vigabatrin have been observed [see Warnings and Precautions ( 5.3 , 5.4 )] . Juvenile Animal Toxicity Data Oral administration of vigabatrin (5, 15, or 50 mg/kg/day) to young rats during the neonatal and juvenile periods of development (postnatal days 4 to 65) produced neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain gray matter vacuolation, decreased myelination, and retinal dysplasia) abnormalities .

The no-effect dose for developmental neurotoxicity in juvenile rats (the lowest dose tested) was associated with plasma vigabatrin exposures (AUC) substantially less than those measured in pediatric patients at recommended doses. In dogs, oral administration of vigabatrin (30 or 100 mg/kg/day) during selected periods of juvenile development (postnatal days 22 to 112) produced neurohistopathological abnormalities (brain gray matter vacuolation). Neurobehavioral effects of vigabatrin were not assessed in the juvenile dog.

A no-effect dose for neurohistopathology was not established in juvenile dogs; the lowest effect dose (30 mg/kg/day) was associated with plasma vigabatrin exposures lower than those measured in pediatric patients at recommended doses [see Warnings and Precautions ( 5.4 )].

🧓 Geriatric Use 192 words ▾

8.5Geriatric Use Clinical studies of vigabatrin did not include sufficient numbers of patients aged 65 and over to determine whether they responded differently from younger patients. Vigabatrin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Oral administration of a single dose of 1.5 g of vigabatrin to elderly (≥65 years) patients with reduced creatinine clearance (<50 mL/min) was associated with moderate to severe sedation and confusion in 4 of 5 patients, lasting up to 5 days. The renal clearance of vigabatrin was 36% lower in healthy elderly subjects (≥65 years) than in young healthy males. Adjustment of dose or frequency of administration should be considered.

Such patients may respond to a lower maintenance dose [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 ) ] . Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 213 words ▾

10 OVERDOSAGE

10.1Signs, Symptoms, and Laboratory Findings of Overdosage Confirmed and/or suspected vigabatrin overdoses have been reported during clinical trials and in post marketing surveillance. No vigabatrin overdoses resulted in death. When reported, the vigabatrin dose ingested ranged from 3 g to 90 g, but most were between 7.5 g and 30 g.

Nearly half the cases involved multiple drug ingestions including carbamazepine, barbiturates, benzodiazepines, lamotrigine, valproic acid, acetaminophen, and/or chlorpheniramine. Coma, unconsciousness, and/or drowsiness were described in the majority of cases of vigabatrin overdose. Other less commonly reported symptoms included vertigo, psychosis, apnea or respiratory depression, bradycardia, agitation, irritability, confusion, headache, hypotension, abnormal behavior, increased seizure activity, status epilepticus, and speech disorder.

These symptoms resolved with supportive care.

10.2Management of Overdosage There is no specific antidote for VIGADRONE overdose. Standard measures to remove unabsorbed drug should be used, including elimination by emesis or gastric lavage. Supportive measures should be employed, including monitoring of vital signs and observation of the clinical status of the patient.

In an in vitro study, activated charcoal did not significantly adsorb vigabatrin. The effectiveness of hemodialysis in the treatment of VIGADRONE overdose is unknown. In isolated case reports in renal failure patients receiving therapeutic doses of vigabatrin, hemodialysis reduced vigabatrin plasma concentrations by 40% to 60%.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism of vigabatrin’s anti-seizure effect is unknown, but it is believed to be the result of its action as an irreversible inhibitor of γ-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system. No direct correlation between plasma concentration and efficacy has been established.

The duration of drug effect is presumed to be dependent on the rate of enzyme re-synthesis rather than on the rate of elimination of the drug from the systemic circulation.

12.2Pharmacodynamics Effects on Electrocardiogram There is no indication of a QT/QTc prolonging effect of vigabatrin in single doses up to 6.0 g. In a randomized, placebo-controlled, crossover study, 58 healthy subjects were administered a single oral dose of vigabatrin (3 g and 6 g) and placebo. Peak concentrations for 6.0 g vigabatrin were approximately 2-fold higher than the peak concentrations following the 3.0 g single oral dose.

12.3Pharmacokinetics Vigabatrin displayed linear pharmacokinetics after administration of single doses ranging from 0.5 g to 4 g, and after administration of repeated doses of 0.5 g and 2.0 g twice daily. Bioequivalence has been established between the oral solution and tablet formulations. The following PK information (T max , half-life, and clearance) of vigabatrin was obtained from stand-alone PK studies and population PK analyses.

Absorption Following oral administration, vigabatrin is essentially completely absorbed. The time to maximum concentration (T max ) is approximately 1 hour for children and adolescents (3 years to 16 years of age) and adults, and approximately 2.5 hours for infants (5 months to 2 years of age). There was little accumulation with multiple dosing in adult and pediatric patients.

A food effect study involving administration of vigabatrin to healthy volunteers under fasting and fed conditions indicated that the C max was decreased by 33%, T max was increased to 2 hours, and AUC was unchanged under fed conditions. Distribution Vigabatrin does not bind to plasma proteins. Vigabatrin is widely distributed throughout the body; mean steady-state volume of distribution is

1.1L/kg (CV = 20%). Metabolism and Elimination Vigabatrin is not significantly metabolized; it is eliminated primarily through renal excretion. The terminal half-life of vigabatrin is about 5.7 hours for infants (5 months to 2 years of age), 6.8 hours for children (3 to 9 years of age), 9.5 hours for children and adolescents (10 to 16 years of age) and 10.5 hours for adults.

Following administration of [14] C- vigabatrin to healthy male volunteers, about 95% of total radioactivity was recovered in the urine over 72 hours with the parent drug representing about 80% of this. Vigabatrin induces CYP2C9 but does not induce other hepatic cytochrome P450 enzyme systems. Specific Populations Geriatric The renal clearance of vigabatrin in healthy elderly patients (≥65 years of age) was 36% less than those in healthy younger patients.

This finding is confirmed by an analysis of data from a controlled clinical trial [see Use in Specific Populations ( 8.5 )] . Pediatric The clearance of vigabatrin is

2.4 L/hr for infants (5 months to 2 years of age),

5.1 L/hr for children (3 to 9 years of age),

5.8L/hr for children and adolescents (10 to 16 years of age) and 7 L/hr for adults. Gender No gender differences were observed for the pharmacokinetic parameters of vigabatrin in patients. Race No specific study was conducted to investigate the effects of race on vigabatrin pharmacokinetics.

A cross study comparison between 23 Caucasian and 7 Japanese patients who received 1, 2, and 4 g of vigabatrin indicated that the AUC, C max , and half-life were similar for the two populations. However, the mean renal clearance of Caucasians (5.2 L/hr) was about 25% higher than the Ja… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 98 words ▾

12.1Mechanism of Action The precise mechanism of vigabatrin’s anti-seizure effect is unknown, but it is believed to be the result of its action as an irreversible inhibitor of γ-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system. No direct correlation between plasma concentration and efficacy has been established.

The duration of drug effect is presumed to be dependent on the rate of enzyme re-synthesis rather than on the rate of elimination of the drug from the systemic circulation.

📦 How Supplied / Storage and Handling 102 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied VIGADRONE ® for oral solution is available as 500 mg packets containing a white to off-white granular powder. They are supplied in cartons of 50 packets (NDC 0245-0556-50). The oral syringes are provided separately by the pharmacy.

16.2Storage and Handling Store at 20° to 25°C (68° to 77°F). See USP Controlled Room Temperature.

16.1How Supplied VIGADRONE ® for oral solution is available as 500 mg packets containing a white to off-white granular powder. They are supplied in cartons of 50 packets (NDC 0245-0556-50). The oral syringes are provided separately by the pharmacy.

📦 Storage and Handling 17 words ▾

16.2Storage and Handling Store at 20° to 25°C (68° to 77°F). See USP Controlled Room Temperature.

📋 Description 203 words ▾

11 DESCRIPTION VIGADRONE (vigabatrin, USP) is an oral antiepileptic drug and is available as a white to off-white granular powder for oral solution in packets of 500 mg. The chemical name of vigabatrin, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C 6 H 11 NO 2 and the molecular weight is 129.16.

It has the following structural formula: Vigabatrin, USP is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P= -1.96) at physiologic pH.

Vigabatrin melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pK a ) of vigabatrin are 4 and 9.7 at room temperature (25°C). VIGADRONE for oral solution is available as a white to off-white granular powder.

Each packet contains 500 mg of vigabatrin. The structural formula for vigabatrin, a racemate consisting of two enantiomers, is (±) 4 amino-5 hexenoic acid. The molecular formula is C6H11NO2 and the molecular weight is 129.16.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients and caregivers to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Administration Instructions for VIGADRONE for Oral Solution Physicians should confirm that caregiver(s) understand how to mix VIGADRONE for Oral Solution and to administer the correct dose to their infants and pediatric patients [see Dosage and Administration ( 2.5 )] . Permanent Vision Loss Inform patients and caregivers of the risk of permanent vision loss, particularly loss of peripheral vision, from VIGADRONE, and the need for monitoring vision [see Warnings and Precautions ( 5.1 )] .

Monitoring of vision, including assessment of visual fields and visual acuity, is recommended at baseline (no later than 4 weeks after starting VIGADRONE), at least every 3 months while on therapy, and about 3 to 6 months after discontinuation of therapy. In patients for whom vision testing is not possible, treatment may continue without recommended testing according to clinical judgment with appropriate patient or caregiver counseling. Patients or caregivers should be informed that if baseline or subsequent vision is not normal, VIGADRONE should only be used if the benefits of VIGADRONE treatment clearly outweigh the risks of additional vision loss.

Advise patients and caregivers that vision testing may be insensitive and may not detect vision loss before it is severe. Also advise patients and caregivers that if vision loss is documented, such loss is irreversible. Ensure that both of these points are understood by patients and caregivers.

Patients and caregivers should be informed that if changes in vision are suspected, they should notify their physician immediately. V igabatrin REMS Program VIGADRONE is available only through a restricted program called the Vigabatrin REMS Program [see Warnings and Precautions ( 5.2 )] . Inform patients/caregivers of the following: Patients/caregivers must be enrolled in the program.

VIGADRONE is only available through pharmacies that are enrolled in the Vigabatrin REMS Program. MRI Abnormalities in Infants Inform caregiver(s) of the possibility that infants may develop an abnormal MRI signal of unknown clinical significance [see Warnings and Precautions ( 5.3 )] . Suicidal Thinking and Behavior Counsel patients, their caregiver(s), and families that AEDs, including VIGADRONE, may increase the risk of suicidal thoughts and behavior.

Also advise patients and caregivers of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions ( 5.5 )]. Pregnancy Advise pregnant women and women of child-bearing potential that the use of VIGADRONE during pregnancy can cause fetal harm which may occur early in pregnancy before many women know they are pregnant.

Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Advise patients that there is a pregnancy exposure registry that collects information about the safety of antiepileptic drugs during pregnancy [see Use in Specific Populations ( 8.1 )] . Nursing Counsel patients that VIGADRONE is excreted in breast milk.

Because of the potential for serious adverse reactions in nursing infants from VIGADRONE, breastfeeding is not recommended. If a decision is made to breastfeed, nursing mothers should be counseled to observe their infants for signs of vision loss, sedation and poor sucking [see Use in Specific Populations ( 8.2 )]. Withdrawal of VIGADRONE Therapy Instruct patients and caregivers not to suddenly discontinue VIGADRONE therapy without consulting with their healthcare provider.

As with all AEDs, withdrawal should normally be gradual [see Warnings and Precautions ( 5.6 )] . Manufactured for UPSHER-SMITH LABORATORIES, LLC… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE VIGADRONE ® (vi-ga-drōne) (vigabatrin) for oral solution What is the most important information I should know about VIGADRONE? VIGADRONE can cause serious side effects, including: Permanent vision loss Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS) Risk of suicidal thoughts or actions 1. Permanent vision loss: VIGADRONE can damage the vision of anyone who takes it.

Some people can have severe loss particularly to their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision.

If this happens, it will not get better. Vision loss and use of VIGADRONE in adults and children 2 years and older: Because of the risk of vision loss, VIGADRONE is used to treat complex partial seizures (CPS) only in people who do not respond well enough to several other medicines. Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting VIGADRONE start to trip, bump into things, or are more clumsy than usual are surprised by people or things coming in front of you that seem to come out of nowhere These changes can mean that you (or your child) have damage to your vision.

It is recommended that your healthcare provider test your (or your child’s) vision (including peripheral vision) and visual acuity (ability to read an eye chart) before you (or your child) start VIGADRONE or within 4 weeks after starting VIGADRONE, and at least every 3 months after that until VIGADRONE is stopped. It is also recommended that you (or your child) have a vision test about 3 to 6 months after VIGADRONE is stopped. Your vision loss may get worse after you stop taking VIGADRONE.

Some people are not able to complete testing of vision. Your healthcare provider will determine if you (or your child) can be tested. If you (or your child) cannot complete vision testing, your healthcare provider may continue prescribing VIGADRONE, but your healthcare provider will not be able to watch for any vision loss you (or your child) may get.

Even if your vision (or your child’s vision) seems fine, it is important that you (or your child) get these regular vision tests because vision damage can happen before you (or your child) notice any changes. These vision tests cannot prevent the vision damage that can happen with VIGADRONE, but they do allow the healthcare provider to decide if you (or your child) should stop VIGADRONE if your vision has gotten worse. Vision testing may not detect vision loss before it is severe.

If you do not have these vision tests regularly, your healthcare provider may stop prescribing VIGADRONE. If you drive and your vision is damaged by VIGADRONE, driving might be more dangerous, or you may not be able to drive safely at all. Talk about this with your healthcare provider.

Vision loss in babies: Because of the risk of vision loss, VIGADRONE is used in babies 1 month to 2 years of age with infantile spasms (IS) only when you and your healthcare provider decide that the possible benefits of VIGADRONE are more important than the risks. Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe.

It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting VIGADRONE or within 4 weeks after starting VIGADRONE, and every 3 months after that until VIGADRONE is stopped. Your baby should also have a vision test about 3 to 6 months after VIGADRONE is stopped. Your baby may not be able to be tested.

Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing VIGADRONE, but your healthcare provider will not be able to watch for a… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Vigabatrin displayed linear pharmacokinetics after administration of single doses ranging from 0.5 g to 4 g, and after administration of repeated doses of 0.5 g and 2.0 g twice daily. Bioequivalence has been established between the oral solution and tablet formulations. The following PK information (T max , half-life, and clearance) of vigabatrin was obtained from stand-alone PK studies and population PK analyses.

Absorption Following oral administration, vigabatrin is essentially completely absorbed. The time to maximum concentration (T max ) is approximately 1 hour for children and adolescents (3 years to 16 years of age) and adults, and approximately 2.5 hours for infants (5 months to 2 years of age). There was little accumulation with multiple dosing in adult and pediatric patients.

A food effect study involving administration of vigabatrin to healthy volunteers under fasting and fed conditions indicated that the C max was decreased by 33%, T max was increased to 2 hours, and AUC was unchanged under fed conditions. Distribution Vigabatrin does not bind to plasma proteins. Vigabatrin is widely distributed throughout the body; mean steady-state volume of distribution is

1.1L/kg (CV = 20%). Metabolism and Elimination Vigabatrin is not significantly metabolized; it is eliminated primarily through renal excretion. The terminal half-life of vigabatrin is about 5.7 hours for infants (5 months to 2 years of age), 6.8 hours for children (3 to 9 years of age), 9.5 hours for children and adolescents (10 to 16 years of age) and 10.5 hours for adults.

Following administration of [14] C- vigabatrin to healthy male volunteers, about 95% of total radioactivity was recovered in the urine over 72 hours with the parent drug representing about 80% of this. Vigabatrin induces CYP2C9 but does not induce other hepatic cytochrome P450 enzyme systems. Specific Populations Geriatric The renal clearance of vigabatrin in healthy elderly patients (≥65 years of age) was 36% less than those in healthy younger patients.

This finding is confirmed by an analysis of data from a controlled clinical trial [see Use in Specific Populations ( 8.5 )] . Pediatric The clearance of vigabatrin is

2.4 L/hr for infants (5 months to 2 years of age),

5.1 L/hr for children (3 to 9 years of age),

5.8L/hr for children and adolescents (10 to 16 years of age) and 7 L/hr for adults. Gender No gender differences were observed for the pharmacokinetic parameters of vigabatrin in patients. Race No specific study was conducted to investigate the effects of race on vigabatrin pharmacokinetics.

A cross study comparison between 23 Caucasian and 7 Japanese patients who received 1, 2, and 4 g of vigabatrin indicated that the AUC, C max , and half-life were similar for the two populations. However, the mean renal clearance of Caucasians (5.2 L/hr) was about 25% higher than the Japanese (4.0 L/hr). Inter-subject variability in renal clearance was 20% in Caucasians and was 30% in Japanese.

Renal Impairment Mean AUC increased by 30% and the terminal half-life increased by 55% (8.1 hr vs 12.5 hr) in adult patients with mild renal impairment (CLcr from >50 to 80 mL/min) in comparison to normal subjects. Mean AUC increased by two-fold and the terminal half-life increased by two-fold in adult patients with moderate renal impairment (CLcr from >30 to 50 mL/min) in comparison to normal subjects. Mean AUC increased by 4.5-fold and the terminal half-life increased by 3.5-fold in adult patients with severe renal impairment (CLcr from >10 to 30 mL/min) in comparison to normal subjects.

Adult patients with renal impairment Dosage adjustment, including starting at a lower dose, is recommended for adult patients with any degree of renal impairment [see Use in Specific Populations ( 8.6 ) and Dosage and Administration ( 2.4 )] . Infants with renal impairment Information about how to adjust the dose in infants with renal impairment is unavailable. Pediatric patients 2 years and old… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 68 words ▾

12.2Pharmacodynamics Effects on Electrocardiogram There is no indication of a QT/QTc prolonging effect of vigabatrin in single doses up to 6.0 g. In a randomized, placebo-controlled, crossover study, 58 healthy subjects were administered a single oral dose of vigabatrin (3 g and 6 g) and placebo. Peak concentrations for 6.0 g vigabatrin were approximately 2-fold higher than the peak concentrations following the 3.0 g single oral dose.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Complex Partial Seizures Adults The effectiveness of vigabatrin as adjunctive therapy in adult patients was established in two U.S. multicenter, double-blind, placebo-controlled, parallel-group clinical studies. A total of 357 adults (age 18 to 60 years) with complex partial seizures, with or without secondary generalization were enrolled (Studies 1 and 2). Patients were required to be on an adequate and stable dose of an anticonvulsant and have a history of failure on an adequate regimen of carbamazepine or phenytoin.

Patients had a history of about 8 seizures per month (median) for about 20 years (median) prior to entrance into the study. These studies were not capable by design of demonstrating direct superiority of vigabatrin over any other anticonvulsant added to a regimen to which the patient had not adequately responded. Further, in these studies, patients had previously been treated with a limited range of anticonvulsants.

The primary measure of efficacy was the patient’s reduction in mean monthly frequency of complex partial seizures plus partial seizures secondarily generalized at end of study compared to baseline. Study 1 Study 1 (N=174) was a randomized, double-blind, placebo-controlled, dose-response study consisting of an 8-week baseline period followed by an 18-week treatment period. Patients were randomized to receive placebo or 1, 3, or 6 g/day vigabatrin administered twice daily.

During the first 6 weeks following randomization, the dose was titrated upward beginning with 1 g/day and increasing by 0.5 g/day on days 1 and 5 of each subsequent week in the 3 g/day and 6 g/day groups, until the assigned dose was reached. Results for the primary measure of effectiveness, reduction in monthly frequency of complex partial seizures, are shown in Table 8. The 3 g/day and 6 g/day dose groups were statistically significantly superior to placebo, but the 6 g/day dose was not superior to the 3 g/day dose.

Table 8. Median Monthly Frequency of Complex Partial Seizures+ N Baseline Endstudy Placebo 45 9.0 8.8 1 g/day Vigabatrin 45 8.5 7.7 3 g/day Vigabatrin 41 8.5 3.7* 6 g/day Vigabatrin 43 8.5 4.5* * p<0.05 compared to placebo + Including one patient with simple partial seizures with secondary generalization only Figure 1 presents the percentage of patients (X-axis) with a percent reduction in seizure frequency (responder rate) from baseline to the maintenance phase at least as great as that represented on the Y-axis. A positive value on the Y-axis indicates an improvement from baseline (i.e., a decrease in complex partial seizure frequency), while a negative value indicates a worsening from baseline (i.e., an increase in complex partial seizure frequency).

Thus, in a display of this type, a curve for an effective treatment is shifted to the left of the curve for placebo. The proportion of patients achieving any particular level of reduction in complex partial seizure frequency was consistently higher for the vigabatrin 3 and 6 g/day groups compared to the placebo group. For example, 51% of patients randomized to vigabatrin 3 g/day and 53% of patients randomized to vigabatrin 6 g/day experienced a 50% or greater reduction in seizure frequency, compared to 9% of patients randomized to placebo.

Patients with an increase in seizure frequency >100% are represented on the Y-axis as equal to or greater than -100%. Figure 1. Percent Reduction from Baseline in Seizure Frequency Study 2 Study 2 (N=183 randomized, 182 evaluated for efficacy) was a randomized, double-blind, placebo-controlled, parallel study consisting of an 8-week baseline period and a 16-week treatment period.

During the first 4 weeks following randomization, the dose of vigabatrin was titrated upward beginning with 1 g/day and increased by 0.5 g/day on a weekly basis to the maintenance dose of 3 g/day. Results for the primary measure of effectiveness, reduction in monthly complex partial seizure frequency, are shown in Table 9. Vigabatrin 3… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 129 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Vigabatrin is not a controlled substance.

9.2Abuse Vigabatrin did not produce adverse events or overt behaviors associated with abuse when administered to humans or animals. It is not possible to predict the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of vigabatrin (e.g., incrementation of dose, drug-seeking behavior).

9.3Dependence Following chronic administration of vigabatrin to animals, there were no apparent withdrawal signs upon drug discontinuation. However, as with all AEDs, vigabatrin should be withdrawn gradually to minimize increased seizure frequency [see Warnings and Precautions ( 5.6 )] .

🔒 Controlled Substance 9 words ▾

9.1Controlled Substance Vigabatrin is not a controlled substance.

🧪 Nonclinical Toxicology 137 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Vigabatrin showed no carcinogenic potential in mouse or rat when given in the diet at doses up to 150 mg/kg/day for 18 months (mouse) or at doses up to 150 mg/kg/day for 2 years (rat). These doses are less than the maximum recommended human dose (MRHD) for infantile spasms (150 mg/kg/day) and for refractory complex partial seizures (3 g/day) on a mg/m 2 basis. Vigabatrin was negative in in vitro (Ames, CHO/HGPRT mammalian cell forward gene mutation, chromosomal aberration in rat lymphocytes) and in in viv o (mouse bone marrow micronucleus) assays.

No adverse effects on male or female fertility were observed in rats at oral doses up to 150 mg/kg/day (approximately ½ the MRHD of 3 g/day on a mg/m 2 basis for refractory complex partial seizures).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 134 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Vigabatrin showed no carcinogenic potential in mouse or rat when given in the diet at doses up to 150 mg/kg/day for 18 months (mouse) or at doses up to 150 mg/kg/day for 2 years (rat). These doses are less than the maximum recommended human dose (MRHD) for infantile spasms (150 mg/kg/day) and for refractory complex partial seizures (3 g/day) on a mg/m 2 basis. Vigabatrin was negative in in vitro (Ames, CHO/HGPRT mammalian cell forward gene mutation, chromosomal aberration in rat lymphocytes) and in in viv o (mouse bone marrow micronucleus) assays.

No adverse effects on male or female fertility were observed in rats at oral doses up to 150 mg/kg/day (approximately ½ the MRHD of 3 g/day on a mg/m 2 basis for refractory complex partial seizures).

📄 Patient Package Insert ~4 min read ▾

INSTRUCTIONS FOR USE VIGADRONE ® (vi-ga-drōne) ( vigabatrin) for o ral s olution Read this Instructions for Use before your child starts taking VIGADRONE and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your child’s medical condition or treatment.

Talk to your healthcare provider if you have any questions about the right dose of medicine to give your child or how to mix it. Important Note: VIGADRONE comes in a packet Each packet contains 500 mg of VIGADRONE powder VIGADRONE powder must be mixed with water only. The water may be cold or at room temperature.

Your healthcare provider will tell you: ∙ how many packets of VIGADRONE you will need for each dose ∙ how many milliliters (mL) of water to use to mix one dose of VIGADRONE ∙ how many milliliters (mL) of the powder and water mixture you will need for each dose of medicine VIGADRONE should be given right away after it is mixed Use the oral syringes, provided by the pharmacy, to measure and give the correct dose. Do not use a household teaspoon or tablespoon. Supplies you will need to mix 1 dose of VIGADRONE : The number of packets of VIGADRONE needed for each dose 2 clean cups: 1 for mixing and 1 for water.

The cup used for mixing VIGADRONE should be clear so you can see if the powder is dissolved Water to mix with the VIGADRONE powder One small 3 mL oral syringe and one large 10 mL oral syringe which are provided by the pharmacy. Small spoon or other clean utensil to stir the mixture Scissors Step 1 : Start with 1 of the empty cups and the total number of packets you will need for 1 dose. Step 2 : Before you open the packet, tap it to settle all the powder to the bottom of the packet.

Step 3 : Use a pair of scissors to cut open the VIGADRONE packet along the dotted line. Step 4 : Empty the entire contents of the VIGADRONE packet into 1 of the clean empty cups (see Figure A ). Repeat steps 2 to 4 above to open all of the packets needed for 1 dose of VIGADRONE.

Step 5 : Take the second cup and fill it half way with water (see Figure B ). Do not mix VIGADRONE with anything other than water. You will use the larger oral syringe (10 mL) to draw up the water needed to mix with the powder from the packets.

You will need 10 mL of water for each packet of VIGADRONE . For example: If you are using 1 packet of VIGADRONE, you will need to use 10 mL of water (fill the 10 mL oral syringe 1 time) If you are using 2 packets of VIGADRONE, you will need to use 20 mL of water (fill the 10 mL oral syringe 2 times) If you are using 3 packets of VIGADRONE, you will need to use 30 mL of water (fill the 10 mL oral syringe 3 times) Step 6 : Use the 10 mL oral syringe to draw up 10 mL of water. To do this, put the tip of the oral syringe all the way into the water in your cup.

Then pull the plunger up towards you until the edge of the white plunger is at the 10 mL line on the barrel of the oral syringe (see Figure C ). If you see bubbles of air in the oral syringe after drawing up the water, turn the oral syringe so the tip is pointing up (see Figure D ). The air will move to the top of the oral syringe.

Pull the plunger back towards you and then push it back gently into the oral syringe to get rid of the bubbles. Tiny bubbles are normal. Step 7 : Check the oral syringe to make sure it is filled with water up to the 10 mL line (see Figure E ).

Step 8 : Get the second cup that contains the VIGADRONE needed for your dose. Step 9 : Hold the 10 mL oral syringe that is filled with water with the tip pointing down over the VIGADRONE. Step 10: Slowly push the oral syringe plunger all the way down to empty the water from the oral syringe straight into the cup containing the VIGADRONE (see Figure F ).

Repeat s teps 6 through 10 until all of the water that is needed to mix 1 dose of VIGADRONE has been added to the cup containing the powder. Step 11 : Stir the mixture with the small spoon or other clean utensil… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 19 words ▾

PRINCIPAL DISPLAY PANEL NDC 0245-0556-50 VIGADRONE ® (vigabatrin) for oral solution 500 mg 50 Single-Dose Packets Rx Only carton-aucyun

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

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 this package alone, 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 – Q1 2026 · 5 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
5.4K
Units reimbursed last 4 qtrs
615.1K
Gross reimbursed last 4 qtrs
$56.03M
Avg / prescription
$10,400.34
Avg / unit
$91.0802
Latest quarter Q1 2026
1.2KRx
Fee-for-service vs managed care ⓘ
47% FFS 53% MCO
Fee-for-service · 2,513 Rx Managed care · 2,874 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 2,760 units · 141 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 11,190 units · 195 per 100k residents MN Wisconsin: no data reported WI Michigan: 25,724 units · 256 per 100k residents MI New York: 12,276 units · 62.7 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: 2,040 units · 349 per 100k residents WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 21,504 units · 171 per 100k residents IL Indiana: 26,822 units · 391 per 100k residents IN Ohio: 28,340 units · 240 per 100k residents OH Pennsylvania: 15,299 units · 118 per 100k residents PA New Jersey: 5,280 units · 56.8 per 100k residents NJ Massachusetts: no data reported MA California: 147,395 units · 378 per 100k residents CA Utah: no data reported UT Colorado: 33,572 units · 571 per 100k residents CO Nebraska: 1,410 units · 71.3 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 4,950 units · 56.8 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 10,641 units · 362 per 100k residents KS Arkansas: 1,200 units · 39.1 per 100k residents AR Tennessee: 13,526 units · 190 per 100k residents TN North Carolina: 26,196 units · 242 per 100k residents NC South Carolina: 8,756 units · 163 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 2,700 units · 59.0 per 100k residents LA Mississippi: no data reported MS Alabama: 7,899 units · 155 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 196,595 units · 645 per 100k residents TX Florida: 9,060 units · 40.1 per 100k residents FL
Units reimbursed · per 100k residents
39.1645
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 Texas 645 /100k
2 Colorado 571 /100k
3 Indiana 391 /100k
4 California 378 /100k
5 Kansas 362 /100k
6 Wyoming 349 /100k
7 Michigan 256 /100k
8 North Carolina 242 /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.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Vigadrone — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Vigadrone. 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.
Total Part D spend
$432.9K
Claims incl. refills
33
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$13,117.72
💵 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.
🛡
This drug has a REMS — Vigabatrin REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It is available only through a restricted program (certified prescribers/pharmacies, enrollment, or required monitoring). See the boxed warning & full label below, and REMS@FDA ↗.

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) — 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) ✓ Available
“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 Upsher-Smith Laboratories, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Upsher-Smith Laboratories, 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.
← 00245-0412-01 · Upsher-Smith 00245-0570-01 · Upsher-Smith →
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.