HomeNDC LookupIngredientsPhenobarbital › 71205-0845-55
Phenobarbital 15 mg Tablet, 500-count — NDC 71205-0845-55 package photo

Phenobarbital 15 mg Tablet, 500-count

by Proficient Rx LP · 500 TABLET in 1 BOTTLE (71205-845-55)
NDC 71205-0845-55
🏷️ FDA NDC (as labeled) 71205-845-55 billing pads the product segment with a zero
This package
Contains500-count Pack sizes9 compare ↓
Also priced by: Part D plans $0.2071/unit — full pricing hub ↓
Rx only On market CIV
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 71205-845-55
Product NDC 71205-845
11-digit billing NDC 71205084555
NCPDP billing unit EA — each (per item)
RxCUI 198083, 198089, 312357
UNII YQE403BP4D
UPC 0371205851309, 0371205848309, 0371205845308
SPL Set ID 6cf88fef-0c82-4d5d-85e8-5896ac013165
DEA schedule CIV
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-11-01
Route ORAL
Dosage form TABLET
Substance PHENOBARBITAL
GCN Seq No 003589
GCN 12971
HICL code 001561
Ingredient (HICL) Phenobarbital
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 PHENOBARBITAL 15 MG TABLET
FDB brand name Phenobarbital
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 71205-845-55 — 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 → 71205-0845-55. 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.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Labeler code71205
First marketedNov 2020
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio1,723 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PHENOBARBITAL 15 MG TABLET Ingredient Phenobarbital
📖 What it is MedlinePlus · NLM

Phenobarbital is used to control seizures. Phenobarbital is also used to relieve anxiety. It is also used to prevent withdrawal symptoms in people who are dependent ('addicted'; feel a need to continue taking the medication) on another barbiturate medication and are going to stop taking the medication. Phenobarbital is in a class of medications called barbiturates. It works by slowing activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Phenobarbital is mainly used to control seizures — including generalized tonic-clonic seizures (sometimes called grand mal seizures) and partial seizures. It's also used as a sedat...
  • What is phenobarbital actually used for?
  • Please don't stop it on your own. Phenobarbital can cause physical dependence, and stopping it suddenly — especially after taking it for a while — can trigger serious withdrawal sy...
  • Can I just stop taking phenobarbital if I feel better?
📖 Read our full Phenobarbital guide →
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.

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.

💊 What it looks like

Color White
ShapeRound
ImprintT;38
Size12 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2071 $103.55 / 500 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenobarbital 15 mg 00143-1495-01 Hikma 100 tablets $0.071 Availability likely
Phenobarbital 15 mg 13811-0300-10 Trigen 100 tablets $0.071 Availability likely
Phenobarbital 15 mg 69367-0438-01 Westminster 100 tablets $0.071 Availability likely
Phenobarbital 15 mg 69367-0691-01 Westminster 100 tablets $0.071 Availability likely
Phenobarbital 15 mg 75826-0136-10 WINDER 100 tablets $0.071 Availability likely
Phenobarbital 15 mg 16571-0670-01 Rising 100 tablets FDA listed
Phenobarbital 15 mg 51672-5331-01 Sun 100 tablets FDA listed
Phenobarbital 15 mg 58118-0572-08 Clinical 30 tablets FDA listed
Phenobarbital 15 mg 62135-0409-05 Chartwell 500 tablets FDA listed
Phenobarbital 15 mg 64950-0571-01 Genus 100 tablets FDA listed
Phenobarbital 15 mg 70752-0165-10 QUAGEN 100 tablets FDA listed
Phenobarbital 15 mgthis 71205-0845-55 Proficient 500 tablets FDA listed
Phenobarbital 15 mg 72162-1581-01 Bryant 100 tablets Discontinued
Phenobarbital 15 mg 82804-0996-00 Proficient 100 tablets FDA listed
Phenobarbital 15 mg 62135-0510-90 Chartwell 90 tablets FDA listed
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

🏛️
2020
On the market since
Nov 2020
📍
2026
Currently FDA-listed
6 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Phenobarbital — the program that covers self-administered drugs. 13 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. 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
$2.62M
Claims incl. refills
93K
Beneficiaries
41.5K
Spend / beneficiary
$63.13
Spend / claim
$28.15
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 Phenobarbital — the ingredient across all brands.

Top reported reactions

Seizure1,669
Drug Interaction658
Toxicity To Various Agents647
Status Epilepticus532
Somnolence492
Multiple-drug Resistance475
Fall464

Reporter sex

15,690 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Disabling336
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,323 409
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71205-0845-00 100 TABLET in 1 BOTTLE (71205-845-00) 2023-02-13 Active
71205-0845-11 1000 TABLET in 1 BOTTLE (71205-845-11) 2023-02-13 Active
71205-0845-30 30 TABLET in 1 BOTTLE (71205-845-30) 2023-02-13 Active
71205-0845-55 You're viewing this 500 TABLET in 1 BOTTLE (71205-845-55) 2023-02-13 Active
71205-0845-60 60 TABLET in 1 BOTTLE (71205-845-60) 2023-02-13 Active
71205-0845-64 240 TABLET in 1 BOTTLE (71205-845-64) 2023-02-13 Active
71205-0845-72 120 TABLET in 1 BOTTLE (71205-845-72) 2023-02-13 Active
71205-0845-78 180 TABLET in 1 BOTTLE (71205-845-78) 2023-02-13 Active
71205-0845-90 90 TABLET in 1 BOTTLE (71205-845-90) 2023-02-13 Active

You're viewing one of 9 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71205-0845-55?
NDC 71205-0845-55 is a 500-count package — 500 tablet in 1 bottle.
What is the difference between NDC 71205-0845-55 and NDC 71205-0845-30?
Both are Phenobarbital 15 mg Tablet — the drug itself is identical. NDC 71205-0845-55 is the 500-count package, while NDC 71205-0845-30 is the 30 tablets package.
What NDC number is used to bill for this package of Phenobarbital 15 mg Tablet?
Bill NDC 71205-0845-55 — the 11-digit billing format is 71205084555. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — 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 "Unapproved Drug Other". 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.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71205-845-55, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71205-0845-55, written without dashes as 71205084555. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71205-0845-55, the first segment (71205) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0845) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (55) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 8 other package presentations of this same product, including 30 tablets (71205-0845-30), 60 tablets (71205-0845-60), 90 tablets (71205-0845-90). 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?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 15 words

INDICATIONS AND USAGE Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.

⏱️ Dosage and Administration 65 words

DOSAGE AND ADMINISTRATION Oral Sedative Dose, Adults - 30 to 120 mg daily in 2 or 3 divided doses. Children - 6 mg/kg of body weight daily in 3 divided doses. Oral Hypnotic Dose, Adults - 100 to 320 mg. Oral Anticonvulsant Dose, Adults - 50 to 100 mg 2 or 3 times daily. Children - 15 to 50 mg 2 or 3 times daily.

Contraindications 103 words

CONTRAINDICATIONS Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates. In such patients, severe hepatic damage can occur from ordinary doses and is usually associated with dermatitis and involvement of parenchymatous organs. A personal or familial history of acute intermittent porphyria represents one of the few absolute contraindications to the use of barbiturates.

Phenobarbital is also contraindicated in patients with marked impairment of liver function, or respiratory disease in which dyspnea or obstruction is evident. It should not be administered to persons with known previous addiction to the sedative/hypnotic group, since ordinary doses may be ineffectual and may contribute to further addiction.

⚠️ Warnings 38 words

WARNINGS In small doses, the barbiturates may increase the reaction to painful stimuli. Taken by themselves, the barbiturates cannot be relied upon to relieve pain or even to produce sedation or sleep in the presence of severe pain.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS The following adverse reactions have been reported: CNS Depression: Residual sedation or “hangover”, drowsiness, lethargy, and vertigo. Emotional disturbances and phobias may be accentuated. In some persons, barbiturates such as phenobarbital repeatedly produce excitement rather than depression, and the patient may appear to be inebriated.

Like other non-analgesic hypnotic drugs, barbiturates, such as phenobarbital, when given in the presence of pain, may cause restlessness, excitement, and even delirium. Rarely, the use of barbiturates results in localized or diffused myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia. The pain may appear in paroxysms, is most intense in the early morning hours, and is most frequently located in the region of the neck, shoulder girdle, and upper limbs.

Symptoms may last for days after the drug is discontinued. Respiratory/Circulatory: Respiratory depression, apnea, circulatory collapse. Allergic: Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions.

Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs.

In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. Other: Nausea and vomiting; headache. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 96 words

Drug Interactions: Phenobarbital in combination with alcohol, tranquilizers, and other central nervous system depressants has additive depressant effects, and the patient should be so advised. Patients taking this drug should be warned not to exceed the dosage recommended by their physician. Toxic effects and fatalities have occurred following overdoses of phenobarbital alone and in combination with other central nervous system depressants.

Caution should be exercised in prescribing unnecessarily large amounts of phenobarbital for patients who have a history of emotional disturbances or suicidal ideation or who have misused alcohol and other CNS drugs (see OVERDOSAGE ).

🤰 Pregnancy 63 words

Usage in Pregnancy: Pregnancy Category B - Reproduction studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to phenobarbital. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🆘 Overdosage ~1 min read

OVERDOSAGE The signs and symptoms of barbiturate poisoning are referable especially to the central nervous system and the cardiovascular system. Moderate intoxication resembles alcoholic inebriation. In severe intoxication, the patient is comatose, the level of reflex activity conforming in a general way to the intensity of the central depression.

The deep reflexes may persist for some time despite coexistent coma. The Babinski sign is often positive. The EEG may be of the “burst-suppression” type, with brief periods of electrical silence.

The pupils may be constricted and react to light, but late in the course of barbiturate poisoning they may show hypoxic paralytic dilatation. Respiration is affected early. Breathing may be either slow or rapid and shallow; Cheyne-Stokes rhythm may be present.

Respiratory minute volume is diminished, and hypoxia and respiratory acidosis may develop. The blood pressure falls, owing partly to depression of medullary vasomotor centers; partly to a direct action of the drug on the myocardium, sympathetic ganglia, and vascular smooth muscle; partly to hypoxia. The patient thus develops a typical shock syndrome, with a weak and rapid pulse, cold and clammy skin, and a rise in the hematocrit.

Respiratory complications (atelectasis, pulmonary edema, and bronchopneumonia) and renal failure are much dreaded and not infrequent concomitant of severe barbiturate poisoning. There is usually hypothermia, sometimes with temperatures as low as 32°C. Treatment: General management should consist of symptomatic and supportive therapy, including gastric lavage, administration of intravenous fluids, and maintenance of blood pressure, body temperature and adequate respiratory exchange.

Dialysis will increase the rate of removal of barbiturates from the body fluids. Antibiotics may be required to control pulmonary complications.

🧬 Clinical Pharmacology 48 words

CLINICAL PHARMACOLOGY Phenobarbital, a long-acting barbiturate, is a central nervous system depressant. In ordinary doses, the drug acts as a sedative and anticonvulsant. Its onset of action occurs within 30 minutes, and the duration of action ranges from 5 to 6 hours. It is detoxified in the liver.

📦 How Supplied / Storage and Handling ~1 min read

HOW SUPPLIED Phenobarbital Tablets, USP 15 mg: White to off-white round, biconvex tablets debossed “T35” on one side and plain on the other side. Available in bottles of 30 tablets, NDC 71205-845-30; 60 tablets, NDC 71205-845-60; 90 tablets, NDC 71205-845-90; 100 tablets, NDC 71205-845-00; 120 tablets, NDC 71205-845-72; 180 tablets, NDC 71205-845-78; 240 tablets, NDC 71205-845-64; 500 tablets, NDC 71205-845-55; and 1000 tablets, NDC 71205-845-11. Phenobarbital Tablets, USP 60 mg: White to off-white round, biconvex tablets debossed “T” above and “37” below the bisect on one side and plain on the other side.

Available in bottles of 30 tablets, NDC 71205-848-30; 60 tablets, NDC 71205-848-60; 90 tablets, NDC 71205-848-90; 100 tablets, NDC 71205-848-00; 120 tablets, NDC 71205-848-72; 180 tablets, NDC 71205-848-78; 240 tablets, NDC 71205-848-64; 500 tablets, NDC 71205-848-55; and 1000 tablets, NDC 71205-848-11. Phenobarbital Tablets, USP 100 mg: White to off-white round, biconvex tablets debossed “T” above and “38” below the bisect on one side and plain on the other side. Available in bottles of 30 tablets, NDC 71205-851-30; 60 tablets, NDC 71205-851-60; 90 tablets, NDC 71205-851-90; 100 tablets, NDC 71205-851-00; 120 tablets, NDC 71205-851-72; 180 tablets, NDC 71205-851-78; 240 tablets, NDC 71205-851-64; 500 tablets, NDC 71205-851-55; and 1000 tablets, NDC 71205-851-11.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 52024 Rev. 07/20

📋 Description 101 words

DESCRIPTION Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C 12 H 12 N 2 O 3 (232.24).

The structural formula is as follows: Each Phenobarbital Tablet, USP contains 15 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate. Structure

💬 Information for Patients 33 words

Information for Patients: Phenobarbital may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly.

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