PHENOBARBITAL 60 mg Tablet, 500-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Barbiturates and derivatives class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Phenobarbital — tap one for details:
Phenobarbital may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
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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.
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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.
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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.
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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.
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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?
ingredient 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?
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💲 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 system | Per each | Per 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?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Phenobarbital 60 mg 00143-1455-01 | Hikma | 100 tablets | $0.182 | — | Availability likely | — |
| Phenobarbital 60 mg 13517-0693-01 | e5 | 100 tablets | $0.182 | — | Availability likely | — |
| Phenobarbital 60 mg 13811-0302-10 | Trigen | 100 tablets | $0.182 | — | Availability likely | — |
| Phenobarbital 60 mg 16571-0674-01 | Rising | 100 tablets | $0.182 | — | Availability likely | — |
| Phenobarbital 60 mg 69367-0442-01 | Westminster | 100 tablets | $0.182 | — | Availability likely | — |
| Phenobarbital 60 mg 69367-0693-01 | Westminster | 100 tablets | $0.182 | — | Availability likely | — |
| Phenobarbital 60 mg 75826-0140-10 | WINDER | 100 tablets | $0.182 | — | Availability likely | — |
| Phenobarbital 60 mg 51672-5333-01 | Sun | 100 tablets | — | — | FDA listed | — |
| Phenobarbital 60 mg 62135-0411-05 | Chartwell | 500 tablets | — | — | FDA listed | — |
| Phenobarbital 60 mg 64950-0575-01 | Genus | 100 tablets | — | — | FDA listed | — |
| Phenobarbital 60 mgthis 70752-0167-14 | QUAGEN | 500 tablets | — | — | FDA listed | — |
| Phenobarbital 60 mg 71205-0848-00 | Proficient | 100 tablets | — | — | FDA listed | — |
| Phenobarbital 60 mg 72162-1583-01 | Bryant | 100 tablets | — | — | Discontinued | — |
| Phenobarbital 60 mg 82804-0998-00 | Proficient | 100 tablets | — | — | FDA listed | — |
| Phenobarbital 60 mg 62135-0515-90 | Chartwell | 90 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70752-0167-10 | 100 TABLET in 1 BOTTLE (70752-167-10) | 2020-09-30 | Active |
| 70752-0167-11 | 1000 TABLET in 1 BOTTLE (70752-167-11) | 2020-09-30 | Active |
| 70752-0167-14 You're viewing this | 500 TABLET in 1 BOTTLE (70752-167-14) | 2020-09-30 | Active |
You're viewing one of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 70752-0167-14?
What is the difference between NDC 70752-0167-14 and NDC 70752-0167-10?
What NDC number is used to bill for this package of PHENOBARBITAL 60 mg Tablet?
🧭 About this NDC listing & data coverage
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. |
Questions about this listing
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Is the NDC printed on the package the same as the 11-digit billing NDC?
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Does this product come in other package sizes?
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.
⏱️ Dosage and Administration ▾
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 ▾
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 ▾
WARNING: MAY BE HABIT-FORMING
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 ▾
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 ▾
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 ▾
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 ▾
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.
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 ▾
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 ▾
HOW SUPPLIED Phenobarbital T ab l e t s , 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 100 tablets, NDC 70752-165-10; 500 tablets, 70752-165-14; and 1000 tablets, NDC 70752-165-11. Phenobarbital T ab l e t s , USP 30 mg: White to off-white round, biconvex tablets debossed “T” above and “36” below the bisect on one side and plain on the other side.
Available in bottles of 100 tablets, NDC 70752-166-10; 500 tablets, NDC 70752-166-14; and 1000 tablets, NDC 70752-166-11. Phenobarbital T ab l e t s , 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 100 tablets, NDC 70752-167-10; 500 tablets, NDC 70752-167-14; and 1000 tablets, NDC 70752-167-11.
Phenobarbital T ab l e t s , 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 100 tablets, NDC 70752-168-10; 500 tablets, NDC 70752-168-14; and 1000 tablets, NDC 70752-168-11.
📦 Storage and Handling ▾
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.
📋 Description ▾
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, 30 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. image description
💬 Information for Patients ▾
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.