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Sezaby phenobarbital sodium 100 mg Injection, 1 injection — NDC 62756-301-01 (Billing 62756-0301-01)

by Sun Pharmaceutical Industries, Inc. · 1 INJECTION in 1 VIAL, SINGLE-DOSE

This is a package of 1 injection of Sezaby phenobarbital sodium 100 mg Injection from Sun Pharmaceutical Industries, Inc., marketed since Dec 2022 and currently FDA-listed. It is this product's only package size.

NDC 62756-0301-01
🏷️ FDA NDC (as labeled) 62756-301-01 billing pads the product segment with a zero
Rx only Brand On market CIV ⇄ 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

NDC database record

One package, one record: these facts belong to NDC 62756-301-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
62756 labeler · 301 product · 01 package
Package marketed since
Dec 26, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
1 EA per package
Barcode (UPC)
0362756301016
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62756-301-01
Product NDC 62756-301
11-digit billing NDC 62756030101
NCPDP billing unit EA — each (per item)
RxCUI 2624719, 2624724
UNII SW9M9BB5K3
UPC 0362756301016
Application # NDA215910
SPL Set ID 8c7d0402-4977-4c25-bc4b-11db91339e9a
DEA schedule CIV
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-25
Route INTRAVENOUS
Dosage form INJECTION
Substance PHENOBARBITAL SODIUM

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

GPI-14 60100060102110
GCN Seq No 084058
GCN 53189
HICL code 001560
Ingredient (HICL) Phenobarbital Sodium
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2D
Therapeutic class — specific (HIC3) Barbiturates
AHFS code 28:12.04.00
AHFS class Barbiturates (Anticonvulsants)
FDB label name SEZABY 100 MG VIAL
FDB brand name Sezaby
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084058
  • GCN: 53189
  • GPI-14 (Medi-Span): 60100060102110
  • HICL (First Databank): 001560
  • AHFS class code: 28:12.04.00
  • RxCUI (RxNorm): 2624719
Why two NDCs? The FDA registers this code as 62756-301-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62756-0301-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Barbiturates and derivatives class.

Drug family (ATC) Barbiturates and 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 SEZABY 100 MG VIAL Ingredient Phenobarbital Sodium
📗 Our plain-language guide HelloPharmacist
  • It is used as a sedative and to control seizures. The tablets and oral solutions cover both. The injections have additional uses, such as short-term insomnia, sedation before surge...
  • Please don't stop on your own. Phenobarbital can cause physical dependence, and stopping suddenly can lead to withdrawal problems like delirium and seizures. If you need to stop, y...
  • No, this is a big one. Alcohol and other sedating drugs add to the drowsiness. Opioid pain medicines combined with phenobarbital can cause dangerously slow breathing, coma and deat...
  • Is it safe to drink alcohol or take pain medicine with it?
📖 Read our full Phenobarbital guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
11
Nutrient depletion considerations

Phenobarbital may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Phenobarbital 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62756-0301-01 You're viewing this Main listing 1 INJECTION in 1 VIAL, SINGLE-DOSE 2022-12-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sezaby 100 mgthis 62756-0301-01 Sun 1 injection — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2022
First FDA approval
Nov 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2042
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 17, 2022 RLD RS ⏳ ~15.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11857683 — method of use (U-3779)
US 12636254 — method of use (U-3779)
Exclusivity ODE-414
2022 2024 2026 2028 2030 2032 2034 2036 2038 2040 2042
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 11857683 ↗ Method of use U-3779 Apr 7, 2042
US 12636254 ↗ Method of use U-3779 Apr 7, 2042
FDA exclusivity
CodeWhat it grantsExpires
ODE-414Orphan Drug Exclusivity (7-year)Nov 17, 2029
Common questions
Is there a generic version of SEZABY 100 MG VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for SEZABY 100 MG VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2042 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationNDA215910 (NDA)
Labeler code62756
First marketedDec 2022
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio889 products on file

More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 62756

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning ~2 min read ▾

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE, MISUSE AND ADDICTION WITH UNAPPROVED USE IN ADOLESCENTS AND ADULTS Risks from Concomitant Use with Opioids Concomitant use of phenobarbital products, including SEZABY, and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate.

If a decision is made for concomitant use of these drugs, limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions (5.1) and Drug Interactions (7.3)]. Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration than Recommended The continued use of phenobarbital may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.

Although SEZABY is indicated only for short-term use [see Indications and Usage (1) and Dosage and Administration (2)], if used for a longer duration than recommended, abrupt discontinuation or rapid dosage reduction of SEZABY may precipitate acute withdrawal reactions, which can be life-threatening. For patients receiving SEZABY for longer duration than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue SEZABY [see Warnings and Precautions (5.2)]. Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults SEZABY is not approved for use in adolescents or adults.

The unapproved use of SEZABY, in adolescents and adults exposes them to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of phenobarbital commonly involve concomitant use of other drugs, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes [see Warnings and Precaution (5.3)]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE, MISUSE, AND ADDICTION WITH UNAPPROVED USE IN ADOLESCENTS AND ADULTS See full prescribing information for complete boxed warning .

Concomitant use of phenobarbital products, including SEZABY, and opioids may result in profound sedation, respiratory depression, coma, and death. If a decision is made to use concomitantly, limit dosages and durations to the minimum required, and monitor patients for respiratory depression and sedation. (5.1, 7.3) Although SEZABY is indicated only for short-term use (1, 2), if used for a longer duration than recommended, abrupt discontinuation or rapid dosage reduction may precipitate acute withdrawal reactions, which can be life-threatening.

For patients receiving SEZABY for a longer duration than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue SEZABY. (5.2) SEZABY is not approved for use in adolescents or adults. The unapproved use of SEZABY in adolescents and adults exposes them to risks of abuse, misuse, and addiction, which can lead to overdose or death.

(5.3)

🎯 Indications and Usage 34 words ▾

1 INDICATIONS AND USAGE SEZABY is indicated for the treatment of neonatal seizures in term and preterm infants. SEZABY is a barbiturate indicated for the treatment of neonatal seizures in term and preterm infants.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Loading Dose: 20 mg/kg is administered by intravenous infusion over 15 minutes into a large peripheral vein. If clinically indicated, at least 15 minutes after completion of the initial loading dose, a second loading dose may be administered over the subsequent 15 minutes as 20 mg/kg for term infants or 10 mg/kg or 20 mg/kg for preterm infants. The maximum total loading dose is 40 mg/kg.

(2.1) Maintenance Dosage: starting 8 to 12 hours after first loading dose: 4.5 mg/kg/day given in 2 or 3 divided doses (i.e., 1.5 mg/kg every 8 hours or 2.25 mg/kg every 12 hours) up to 5 days. (2.1). Must be reconstituted with 10 mL 0.9 % Sodium Chloride Injection, USP prior to administration.

See additional preparation and administration instructions in the Full Prescribing Information. (2.3)

2.1Recommended Dosage and Administration The recommended dosage of SEZABY in neonates consists of a loading dose(s) followed by maintenance dosage (see Table 1). Administer SEZABY by intravenous infusion (over 15 minutes) into a large peripheral vein to avoid local tissue toxicity [see Warnings and Precautions (5.9)]. SEZABY is for intravenous use only.

Table 1: Recommended Dosage of SEZABY for Neonatal Seizures Loading Dose (maximum total loading dose is 40 mg/kg) First loading dose 20 mg/kg Second loading dose (If clinically indicated) 1 Preterm Infants 10 mg/kg or 20 mg/kg [see Clinical Pharmacology (12.3)] Term Infants 20 mg/kg Maintenance Dosage (total daily dose is 4.5 mg/kg/day and the total duration is up to 5 days) Initiate 8 to 12 hours after first loading dose Option 1 1.5 mg/kg every 8 hours Option 2 2.25 mg/kg every 12 hours 1 If seizures persist or recur any time 15 minutes after completion of the initial loading dose, administer a second loading dose.

(Administer the second loading dose no sooner than 15 minutes after completion of the first loading dose.)

2.2Reconstitution and Additional Administration Instructions Determine the number of vials to be reconstituted based on the patient’s weight and recommended dose. Aseptically reconstitute the lyophilized powder in the vial using 10 mL of 0.9% Sodium Chloride Injection, USP. Swirl the vial gently until contents are completely dissolved.

The reconstituted solution contains 100 mg per 10 mL (10 mg/mL) of phenobarbital sodium. Inspect the vial visually for particulate matter and discoloration prior to administration (the reconstituted solution is clear, colorless, and free from visible particulate matter). Discard the reconstituted solution if it is discolored or contains foreign particles.

Withdraw the appropriate volume from the reconstituted vial for intravenous infusion and administer immediately [see Dosage and Administration (2.3)] . Discard any unused portion of the reconstituted solution left in the vial [see Description (11)].

2.3Storage of Reconstituted Solution If the reconstituted solution is not administered immediately, place the vial back in the original carton to protect it from light and store at either room temperature at 20°C to 25°C (68°F to 77°F) for a maximum of 8 hours or in the refrigerator at 2°C to 8°C (36°F to 46°F) for a maximum of 24 hours. Discard any unused portion of the reconstituted solution after the recommended storage duration.

💊 Dosage Forms and Strengths 40 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 100 mg of phenobarbital sodium as a white to off-white lyophilized powder in a single-dose vial for reconstitution. For injection: 100 mg of phenobarbital sodium lyophilized powder in a single-dose vial for reconstitution

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS SEZABY is contraindicated in patients with: acute porphyrias [see Warnings and Precautions (5.8)], or a history of hypersensitivity reaction to phenobarbital or other barbiturates [see Warnings and Precautions (5.7)] Acute porphyrias (4) Hypersensitivity to phenobarbital or other barbiturates (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Respiratory Depression or Insufficiency: Abnormal respiration has been observed; careful respiratory monitoring is recommended during and after treatment. (5.4) Serious Dermatologic Reactions: Serious and sometimes fatal hypersensitivity reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome, have been reported. SEZABY should be discontinued at the first sign of a rash, unless the rash is clearly not drug related.

(5.5) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity : DRESS can be fatal or life-threatening. If signs or symptoms of DRESS are present, evaluate the patient immediately. Discontinue if an alternative etiology cannot be established.

(5.6) Infusion Site Reactions : SEZABY may cause tissue damage with necrosis; avoid perivascular extravasation or intra-arterial injection. Stop SEZABY if evidence of pain, swelling, discoloration, or temperature change in limb. (5.9) QT Prolongation : Avoid concomitant use of SEZABY in patients who are at significant risk of developing torsade de pointes and with products that may increase the risk of the QTc interval prolongation or products that may increase concentrations of SEZABY.

(5.10)

5.1Risks from Concomitant Use with Opioids Concomitant use of phenobarbital products, including SEZABY, and opioids may result in profound sedation, respiratory depression, coma, and death [see Drug Interactions (7.3)] . Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. If a decision is made for concomitant use of these drugs, limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation.

Practitioners administering SEZABY must have the skills necessary to manage serious cardiorespiratory adverse reactions, including skills in airway management.

5.2Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration Than Recommended The continued use of phenobarbital may lead to clinically significant physical dependence. Although SEZABY is indicated only for short-term use [see Indications and Usage (1) and Dosage and Administration (2)] , if used for a longer duration than recommended, abrupt discontinuation or rapid dosage reduction of SEZABY may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [see Drug Abuse and Dependence (9.3)] .

To reduce the risk of withdrawal reactions in patients receiving SEZABY for a longer duration than recommended, use a gradual taper to discontinue SEZABY (a patient-specific plan should be used to taper the dose). Patients at an increased risk of withdrawal adverse reactions after phenobarbital discontinuation or rapid dosage reduction include those who received higher dosages, or those who had longer durations of use.

5.3Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults SEZABY is not approved for use in adolescents or adults. The unapproved use of SEZABY in adolescents and adults exposes them to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of barbiturates, including phenobarbital, often (but not always) involve the use of doses exceeding the doses used in clinical practice and commonly involve concomitant use of other drugs, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death [see Drug Abuse and Dependence (9.2)] .

5.4Respiratory Depression or Insufficiency In Study 1, 25% of patients treated with phenobarbital developed abnormal respiration [see Adverse Reactions (6.1) and Clinical Studies (14)] . Careful respiratory monitoring is needed during and after the administration of SEZABY.

5.5Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrol…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1)] Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration Than Recommended [see Warnings and Precautions (5.2)] Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults [see Warnings and Precautions (5.3)] Respiratory Depression or Insufficiency [see Warnings and Precautions (5.4)] Serious Dermatologic Reactions [see Warnings and Precautions (5.5)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.6)] Hypersensitivity [see Warnings and Precautions (5.7)] Exacerbation of Porphyria [see Warnings and Precautions (5.8)] Injection Site Reactions [see Warnings and Precautions (5.9)] QT Prolongation [see Warnings and Precautions (5.10)] Embryofetal Toxicity with Unapproved Use in Adolescents and Adults [see Warnings and Precautions (5.11)] Neonatal Adverse Reactions from Unapproved Maternal Phenobarbital Use [see Warnings and Precautions (5.12)] Sedation, Respiratory Depression, and Withdrawal in Neonates Exposed to Phenobarbital Through Breast Milk [see Warnings and Precautions (5.13)] Suicidal Behavior and Ideation with Unapproved use in Adolescents and Adults [see Warnings and Precautions (5.14)] The most common adverse reactions (incidence > 5% patients overall) are abnormal respiration, sedation, feeding disorder, and hypotension.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials 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. The Study 1 was a multicenter, randomized, double-blind, active-controlled study in neonates who were experiencing seizures [see Clinical Studies (14)] . Patients were infants younger than 14 days of age with gestational ages between 36 and 44 weeks.

Overall, 106 neonates (51 female and 55 male) were randomized to receive either phenobarbital (N=42) or levetiracetam (N=64) as their initial treatment. Patients received up to two 15-minute infusions of their initially assigned treatment (loading dose(s)) followed by maintenance treatment of up to 5 days. Mean durations of phenobarbital and levetiracetam treatments were 4.3 and 4 days, respectively.

Table 2 summarizes the adverse reactions that occurred in 2% or more of neonates in Study 1. Incidences are displayed for neonates who received phenobarbital only and for neonates who received levetiracetam only. Because patients in Study 1 were neonates, adverse reactions that are verbally reported could not be assessed in this study.

Table 2: Adverse Reactions That Occurred in At Least 2% of Neonates Overall in Study 1 by Treatment Received Phenobarbital (N = 32)* % Levetiracetam (N = 19) % Respiration abnormal 25 5 Sedation 16 5 Feeding disorder 16 5 Hypotension 16 0 Bradycardia 3 0 Hyponatremia 3 0 Sepsis 3 0 * Fifty-five neonates received both phenobarbital and levetiracetam and they had a similar adverse reaction profile as neonates who received only phenobarbital.

6.2Postmarketing Experience The following adverse reactions associated with the use of phenobarbital in neonates were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular System : Bradycardia, patent ductus arteriosus Dermatologic Reactions : Eczema Hepatic : Abnormal liver function Musculoskeletal : Hypotonia, absent deep tendon reflexes Nervous System : Impa…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS CYP2C9, 2C19, 2E1, UGT Inhibitors: Closely monitor and decrease SEZABY dosage, if needed. (7.1) CYP3A4, 2B6, 2C, UGT Substrates: Substrate dosage adjustment may be needed. (7.1) CNS depressants: Closely monitor for sedation and respiratory depression. (7.2) Drugs that Prolong the QT Interval : Avoid concomitant use. (7.3)

7.1Cytochrome P450- or Uridine 5’-diphospho-glucuronosyltransferase (UGT)-Based Interactions The drug interaction information in Table 3 is based upon published literature in non-neonatal populations, in vitro studies, and the mechanistic knowledge of phenobarbital metabolic pathways [see Clinical Pharmacology (12.3)] . Although the data from the published literature regarding these drug interactions are from non-neonatal populations and the magnitude of the potential drug interactions in neonates have not been characterized, this information still warrants consideration given the potential impact of these possible drug interactions on the safety and efficacy of phenobarbital and CYP2B6, 2C9, 2C19, or UGT substrates in neonates.

Table 3: Drug Interactions with SEZABY Effects of Other Drugs on SEZABY CYP2C9, 2C19, 2E1, Uridine 5'-diphospho-glucuronosyltransferases ( UGT) Inhibitors or Inducers Prevention or Management Closely monitor for adverse reactions (e.g., over sedation, prolonged QTc interval, etc.) when used concomitantly with inhibitors of these enzymes and reduced efficacy (e.g., breakthrough seizure) when used with inducers of these enzymes. Consider titration of the SEZABY maintenance dosage accordingly if concomitant use is unavoidable.

Clinical Effect(s) Phenobarbital is a substrate of CYP2C9, CYP2C19, CYP2E1, and UGTs [see Clinical Pharmacology (12.3)] . It is likely that concomitant use will result in an increase in phenobarbital exposure when used with these inhibitors and a reduction when used with these inducers, which may increase the risk of SEZABY adverse reactions or reduce efficacy, respectively when concomitant use in neonates. Effects of Other Drugs on Sezaby CYP3A, 2B6, 2C(s), UGTs Substrates Prevention or Management Closely monitor neonates when SEZABY is used concurrently with substrates of these enzymes and consider increasing the dosage of the substrate accordingly, unless otherwise advised in its Prescribing Information, if concomitant use is unavoidable.

Clinical Effect(s) Phenobarbital is an inducer of CYP3A, CYP2B6, CYP2C(s), and UGT(s) [see Clinical Pharmacology (12.3)] . It is likely that concomitant use in neonates will result in a decrease in the exposure of these substrates, which may reduce efficacy.

7.2CNS Depressants Closely monitor for signs of sedation and respiratory depression with concomitant use of SEZABY with other CNS depressants, including opioids [see Warnings and Precautions (5.1)] . Phenobarbital may cause sedation and respiratory depression [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)] . Other products that may also cause these adverse reactions may have additive pharmacologic effect and may increase the risk of sedation and respiratory depression.

7.3Drugs that Prolong QT Interval SEZABY may prolong the QT interval [see Warnings and Precautions (5.10) and Clinical Pharmacology (12.2)] . Other products that may also prolong the QTc interval may have additive effects, and products that may increase concentrations of phenobarbital [see Drug Interactions (7.1)] may increase the QT prolongation risk; therefore, avoid concomitant use of SEZABY and these products. If concomitant use of a product that also prolongs the QTc interval or that increases SEZABY concentrations is unavoidable, monitor patients for increased risk of QTc interval prolongation.

👥 Use in Specific Populations 177 words ▾

8 USE IN SPECIFIC POPULATIONS

8.4Pediatric Use The safety and effectiveness of SEZABY have been established for the treatment of neonatal seizures in term and preterm infants, and the information on this use is discussed throughout the labeling. Juvenile Animal Studies In published studies, administration of antiepileptic drugs, including phenobarbital, to neonatal rats during the period of synaptogenesis has been reported to result in widespread apoptotic neurodegeneration in the developing brain and neurobehavioral deficits that persist into adulthood at doses associated with plasma exposures similar to those anticipated at the doses proposed for humans.

The synaptogenetic period in rats is generally thought to correspond in humans to the third trimester of pregnancy through the first 3 to 4 years of life. In rodents, exposure to phenobarbital during the neonatal period has been reported in published literature to result in permanent alterations in male and female reproductive function. Administration of phenobarbital to neonatal rats or hamsters resulted in disruption of testosterone secretory profiles and estrous cyclicity, changes in steroidogenesis, altered sexual behavior, and impaired fertility in adulthood.

🆘 Overdosage 140 words ▾

10 OVERDOSAGE Overdosage of barbiturates, including phenobarbital, is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur.

In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of barbiturates, particularly in combination with other CNS depressants (including alcohol and opioids) may be fatal [see Warnings and Precautions (5.3)] . Markedly elevated blood pressure, heart rate, or respiratory rate raise the concern that additional drugs are involved in the overdosage.

In managing SEZABY overdosage, employ general supportive measures, including intravenous fluids, pressors, and airway maintenance. Consider contacting a poison center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism of action for phenobarbital for the treatment of neonatal seizures is not fully understood, but it is thought to involve potentiation of synaptic inhibition through an action on the GABA A receptor.

12.2Pharmacodynamics Phenobarbital exposure-response relationships and the time course of pharmacodynamic response of phenobarbital in neonates are unknown. Cardiac Electrophysiology The effect of SEZABY on the QTc interval has not been adequately characterized. Nonclinical data suggest a potential for phenobarbital to inhibit the hERG potassium cardiac ionic channel, and QTc prolongation was reported in the literature in adult patients with post-stroke seizures at a mean phenobarbital dose of 130 mg (approximately 1.5 times the recommended loading dose in an average 4.4 kg neonate at 4 weeks) [see Indications and Usage (1), Dosage and Administration (2.1), and Warnings and Precautions (5.10)] .

12.3Pharmacokinetics Mean (± standard deviation) total (bound + unbound) phenobarbital concentrations were evaluated (see Table 4) in term infants younger than 14 days old with gestational ages between 36 and 44 weeks who received either one loading dose (20 mg/kg) or two loading doses (20 mg/kg each) based upon seizure persistence or reoccurrence [see Clinical Studies 14)] . The loading dose(s) was followed by a maintenance dosage of 1.5 mg/kg every 8 hours (total daily dose 4.5 mg/kg/day). A clinically significant difference between term and preterm infants in phenobarbital PK following the first SEZABY loading dose was not predicted.

A second loading dose of either 10 mg/kg or 20 mg/kg of phenobarbital in preterm infants is expected to result in similar plasma concentrations compared to a second loading dose of 20 mg/kg in term infants. In addition, administration of a phenobarbital maintenance dosage of 1.5 mg/kg every 8 hours or 2.25 mg/kg every 12 hours is not expected to result in a clinically significant difference in total phenobarbital plasma concentrations. Table 4: Observed Phenobarbital Concentration Following Intravenous Phenobarbital Administration in Study 1 Time (Hours) Phenobarbital Concentration (mcg/mL) One Loading Dose Followed by the Maintenance Dosage Two Loading Doses 1 Followed by the Maintenance Dosage 1 23 (± 2.7) 26 (± 5.8) 24 23 (± 1.3) 39 (± 9.1) 48 25 (± 1.8) 39 (± 8.2) 1 Second loading dose administered if seizures persisted or reoccurred more than 15 minutes after the first infusion Elimination Published literature reports that the elimination t 1/2 of phenobarbital in neonates is approximately 1 week.

Metabolism Published literature reports that phenobarbital is primarily metabolized by CYP2C9 and to a lesser extent by CYP2C19, CYP2E1, and UGTs. At birth, expression of CYP2C9 is negligible, which results in the longer half-life in neonates compared to older populations in the published literature. Specific Populations There are no clinically significant differences in pharmacokinetics of phenobarbital in neonates administered therapeutic hypothermia.

The effect of sex, race, ethnicity, renal impairment, or hepatic impairment on phenobarbital pharmacokinetics in neonates is unknown. Drug Interaction Studies Clinical Studies and Published Literature No dedicated clinical studies have been conducted in neonates that evaluated the effect of concomitant use of SEZABY with: • CYP2C9, 2C19, 2E1, or UGT inhibitors or inducers on phenobarbital pharmacokinetics • CYP2B6, 2C9, 2C19, or UGT substrates on the pharmacokinetics of these substrates Published literature regarding these interactions in non-neonatal populations should not be used to estimate the magnitude of the change in phenobarbital exposure in neonates due to differences in the expression of CYP2C9 and possibly other phenobarbital metabolic enzymes in term and preterm infants.

Midazolam: Published literature reports a 2.3-fold increase in the clearance of midazolam (CYP3A substrate)…

📦 How Supplied / Storage and Handling 152 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied SEZABY (phenobarbital sodium) for injection is supplied as a sterile white to off-white, lyophilized powder in single-dose clear glass vials containing 100 mg of phenobarbital sodium. Carton Contents NDC One 100 mg single-dose vial NDC 62756-301-01 The vial stopper is not made with natural rubber latex.

16.2Storage and Handling Store unopened vials of SEZABY in original cartons at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Retain in the original carton until use to protect from light. For information on storage of the reconstituted SEZABY, see Dosage and Administration (2.3) .

Manufactured by: Sun Pharmaceutical Medicare Ltd., Baska Ujeti Road, Ujeti, Halol -389350, Gujarat, India Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 ISS. 02/2023 5237784 SEZABY is a trademark of Sun Pharma Advanced Research Company Ltd., used under license

📋 Description 119 words ▾

11 DESCRIPTION Phenobarbital is a barbiturate. Chemically, phenobarbital sodium is 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5-ethyl-5-phenyl-, monosodium salt and has the following structural formula: C 12 H 11 N 2 NaO 3 MW 254.22 The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is very soluble in water, soluble in alcohol and practically insoluble in ether or chloroform. SEZABY (phenobarbital sodium) for injection, for intravenous use, is supplied as sterile white to off white lyophilized powder in a 10 mL tubular glass vial.

Each single-dose vial contains 100 mg of phenobarbital sodium, USP (equivalent to 91.35 mg of phenobarbital). The pH range is 9.20-10.00. SEZABY does not contain benzyl alcohol or propylene glycol. sezaby-1

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 · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Phenobarbital Sodium (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Phenobarbital Sodium. 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
$70.5K
Claims incl. refills
101
Beneficiaries
44
Spend / beneficiary
$1,601.48
Spend / claim
$697.67
💵 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 Phenobarbital sodium — the ingredient across all brands.

Top reported reactions

Seizure67
Epilepsy27
Status Epilepticus21
Pallor18
Sepsis18
Drug Ineffective For Unapproved Indication17
Condition Aggravated15

Age at onset

Neonate14
Infant1
Child8
Adolescent2
Adult25
Elderly26

Reporter sex

402 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization210
Death61
Life-threatening42
Disabling13
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 41 16
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

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, 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.
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.
← 62756-0299-08 · Sun 62756-0303-12 · SUN →
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.