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vigabatrin 50 mg/mL Powder, For Solution — NDC 0591-3955-50 (Billing 00591-3955-50)

by Actavis Pharma, Inc. · 50 PACKET in 1 CARTON / 10 mL in 1 PACKET

This is a package of vigabatrin 50 mg/mL Powder, For Solution from Actavis Pharma, Inc., no longer marketed (first marketed Apr 2018), no longer in the FDA NDC Directory.

NDC 00591-3955-50
🏷️ FDA NDC (as labeled) 0591-3955-50 billing pads the labeler segment with a zero
This package
Contains10 mL in 1 packet Pack sizes2 compare ↓
Product page 00591-3955-00 Also comes in: 10 ml 0591-3955-00
Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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 Jan 2024. 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0591-3955-50
Product NDC 0591-3955
11-digit billing NDC 00591395550
NCPDP billing unit EA — each (per item)
SPL Set ID 4ff8a8da-3cbb-4e83-8878-0d1864dda787
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jan 2024)
Marketing start 2018-04-23
Dosage form POWDER, FOR SOLUTION
Substance VIGABATRIN

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

GPI-14 72170085003020
GPI class Vigabatrin
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 VIGABATRIN 500 MG POWDER PACKT
FDB brand name Vigabatrin
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
Why two NDCs? The FDA registers this code as 0591-3955-50 — 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 → 00591-3955-50. 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.

Clinical

Label name VIGABATRIN 500 MG POWDER PACKT 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 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
00591-3955-50 You're viewing this 50 PACKET in 1 CARTON / 10 mL in 1 PACKET 2020-05-14 — Discontinued by firm
00591-3955-00 0591-3955-00 Main listing 10 mL in 1 BOX — — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 50 packet in 1 carton / 10 ml in 1 packet.
What NDC number is used to bill for this package of vigabatrin 50 mg/mL Powder, For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vigadrone 50 mg/mL 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 —
vigabatrin 50 mg/mLthis 00591-3955-50 Actavis 50 packets — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
Apr 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerActavis Pharma, Inc.
Labeler code00591
First marketedApr 2018
Product typeDrug For Further Processing
Portfolio324 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

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

Medicare Part D (outpatient prescription) spending for Sabril (matched by generic name) — 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 Sabril. CMS lists 4 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
$3.46M
Claims incl. refills
79
Beneficiaries
33
Spend / beneficiary
$104,965.76
Spend / claim
$43,846.46
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 Vigabatrin — the ingredient across all brands.

Top reported reactions

Seizure2,627
Death882
Somnolence581
Pneumonia540
Drug Withdrawal Convulsions476
Vomiting470
Hospitalisation349

Age at onset

Neonate47
Infant471
Child418
Adolescent64
Adult163
Elderly2

Reporter sex

14,491 reports
Male · 51%
Female · 49%
Unknown · 0%

Serious outcomes

Hospitalization4,609
Life-threatening254
Disabling88
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,017 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.

About this NDC listing & data coverage

Listed for further processing / repackaging No longer marketed (per FDA listing data)

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 ml (00591-3955-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Actavis Pharma, Inc. 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.
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.
← 00591-3916-68 · Actavis 00591-3982-60 · Actavis →
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.