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Phenobarbital 64.8 mg Tablet, 100-count — NDC 75826-0141-10 package photo

Phenobarbital 64.8 mg Tablet, 100-count

by WINDER LABORATORIES, LLC · 100 TABLET in 1 BOTTLE, PLASTIC (75826-141-10)
NDC 75826-0141-10
🏷️ FDA NDC (as labeled) 75826-141-10 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1016 NADAC Per package$10.16 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2921/unit · Part D plans $0.1530/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) 75826-141-10
Product NDC 75826-141
11-digit billing NDC 75826014110
NCPDP billing unit EA — each (per item)
UNII YQE403BP4D
UPC 0375826140101, 0375826143102
SPL Set ID 1805bc08-e870-4373-b290-bed1eed87df6
DEA schedule CIV
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-11
Route ORAL
Dosage form TABLET
Substance PHENOBARBITAL
GPI-14 60100060000322
GPI class PHENobarbital
GCN Seq No 027612
GCN 97966
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 64.8 MG TABLET
FDB brand name Phenobarbital
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 75826-141-10 — 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 → 75826-0141-10. 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

LabelerWINDER LABORATORIES, LLC
Labeler code75826
First marketedJun 2019
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio17 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 64.8 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
ImprintW;L;143
Size1 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 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 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 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

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 DailyMed — 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?
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 eaPer package
Retail pharmacies payNADAC · weekly $0.102 $10.16 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2921 $29.21 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1530 $15.30 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.404 $0.093
▼ Down 75% over the last 24 months.
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 64.8 mg 00603-5167-21 Par 100 tablets $0.102 — Availability likely —
Phenobarbital 64.8 mg 13517-0627-01 e5 100 tablets $0.102 — Discontinued —
Phenobarbital 64.8 mg 13811-0306-10 Trigen 100 tablets $0.102 — Availability likely —
Phenobarbital 64.8 mg 16571-0667-01 Rising 100 tablets $0.102 — Availability likely —
Phenobarbital 64.8 mg 69367-0213-01 Westminster 100 tablets $0.102 — Discontinued —
Phenobarbital 64.8 mg 69367-0443-01 Westminster 100 tablets $0.102 — Availability likely —
Phenobarbital 64.8 mg 69367-0627-01 Westminster 100 tablets $0.102 — Availability likely —
Phenobarbital 64.8 mgthis 75826-0141-10 WINDER 100 tablets $0.102 — Availability likely —
Phenobarbital 64.8 mg 51672-5328-01 Sun 100 tablets — — FDA listed —
Phenobarbital 64.8 mg 58118-0576-08 Clinical 30 tablets — — FDA listed —
Phenobarbital 64.8 mg 62135-0407-60 Chartwell 60 tablets — — FDA listed —
Phenobarbital 64.8 mg 63629-2402-01 Bryant 1000 tablets — — FDA listed —
Phenobarbital 64.8 mg 63629-2403-01 Bryant 100 tablets — — FDA listed —
Phenobarbital 64.8 mg 64950-0576-01 Genus 100 tablets — — FDA listed —
Phenobarbital 64.8 mg 67046-0780-03 Coupler 30 tablets — — FDA listed —
Phenobarbital 64.8 mg 67046-1434-03 Coupler 30 tablets — — FDA listed —
Phenobarbital 64.8 mg 70518-4215-00 REMEDYREPACK 30 tablets — — FDA listed —
Phenobarbital 64.8 mg 70752-0163-10 QUAGEN 100 tablets — — FDA listed —
Phenobarbital 64.8 mg 71205-0849-00 Proficient 100 tablets — — FDA listed —
Phenobarbital 64.8 mg 71205-0892-00 Proficient 100 tablets — — FDA listed —
Phenobarbital 64.8 mg 72162-1167-00 Bryant 1000 tablets — — FDA listed —
Phenobarbital 64.8 mg 72162-1265-00 Bryant 1000 tablets — — FDA listed —
Phenobarbital 64.8 mg 82804-0984-00 Proficient 100 tablets — — FDA listed —
Phenobarbital 64.8 mg 70518-4717-00 REMEDYREPACK 100 tablets — — FDA listed —
Phenobarbital 64.8 mg 62135-0557-90 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

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 75826-0141-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.8K
Units reimbursed last 4 qtrs
91K
Gross reimbursed last 4 qtrs
$26.6K
Avg / prescription
$14.81
Avg / unit
$0.2921
Latest quarter Q1 2026
82Rx
Medicaid pays / ea
$0.2921
gross reimbursed
vs
NADAC / ea
$0.1016
acquisition cost
=
Spread
+$0.1905
+188% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
64% FFS 36% MCO
Fee-for-service · 1,152 Rx Managed care · 642 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 802 units · 10.3 per 100k residents WA Idaho: no data reported ID Montana: 1,071 units · 94.6 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 3,845 units · 38.3 per 100k residents MI New York: 6,598 units · 33.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,974 units · 15.7 per 100k residents IL Indiana: 2,684 units · 39.1 per 100k residents IN Ohio: 3,015 units · 25.6 per 100k residents OH Pennsylvania: 3,881 units · 29.9 per 100k residents PA New Jersey: 1,079 units · 11.6 per 100k residents NJ Massachusetts: 930 units · 13.3 per 100k residents MA California: 32,316 units · 82.9 per 100k residents CA Utah: no data reported UT Colorado: 870 units · 14.8 per 100k residents CO Nebraska: 416 units · 21.0 per 100k residents NE Missouri: no data reported MO Kentucky: 1,164 units · 25.7 per 100k residents KY West Virginia: 2,155 units · 122 per 100k residents WV Virginia: 1,133 units · 13.0 per 100k residents VA Maryland: 420 units · 6.8 per 100k residents MD Connecticut: 1,427 units · 39.5 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,020 units · 13.7 per 100k residents AZ New Mexico: 340 units · 16.1 per 100k residents NM Kansas: 525 units · 17.9 per 100k residents KS Arkansas: 960 units · 31.3 per 100k residents AR Tennessee: 776 units · 10.9 per 100k residents TN North Carolina: 1,140 units · 10.5 per 100k residents NC South Carolina: 1,670 units · 31.1 per 100k residents SC Delaware: 687 units · 66.6 per 100k residents DE Oklahoma: 1,560 units · 38.5 per 100k residents OK Louisiana: 2,066 units · 45.2 per 100k residents LA Mississippi: no data reported MS Alabama: 3,910 units · 76.5 per 100k residents AL Georgia: 4,276 units · 38.8 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 4,794 units · 21.2 per 100k residents FL
Units reimbursed · per 100k residents
6.8122
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 122 /100k
2 Montana 94.6 /100k
3 California 82.9 /100k
4 Alabama 76.5 /100k
5 Delaware 66.6 /100k
6 Louisiana 45.2 /100k
7 Connecticut 39.5 /100k
8 Indiana 39.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets75826-0141-00 176 Rx · $2,185
Drug total (last 4 qtrs): 1,970 Rx · 99,022 units · $28,759 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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 Per unit Per pack Marketing startStatus
75826-0141-00 1000 TABLET in 1 BOTTLE, PLASTIC (75826-141-00) $0.1016 / ea $101.59 2019-06-11 Active
75826-0141-10 You're viewing this 100 TABLET in 1 BOTTLE, PLASTIC (75826-141-10) $0.1016 / ea $10.16 2019-06-11 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1016 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 91% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 75826-0141-10?
NDC 75826-0141-10 is a 100-count package — 100 tablet in 1 bottle, plastic.
What is the difference between NDC 75826-0141-10 and NDC 75826-0141-00?
Both are Phenobarbital 64.8 mg Tablet — the drug itself is identical. NDC 75826-0141-10 is the 100-count package, while NDC 75826-0141-00 is the 1000 tablets package.
What NDC number is used to bill for this package of Phenobarbital 64.8 mg Tablet?
Bill NDC 75826-0141-10 — the 11-digit billing format is 75826014110. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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) ✓ Available
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) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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.
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 75826-141-10, 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: 75826-0141-10, written without dashes as 75826014110. 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 75826-0141-10, the first segment (75826) is the labeler code FDA assigned to WINDER LABORATORIES, LLC; the middle segment (0141) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 WINDER LABORATORIES, LLC. 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 1 other package presentation of this same product, including 1000 tablets (75826-0141-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
WINDER LABORATORIES, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 60 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 nonanalgesic 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 Winder Laboratories, LLC at 1-770-307-0703, 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 70 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 and under the supervision of a physician .

🆘 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 ~2 min read ▾

HOW SUPPLIED Phenobarbital Tablets, USP 15 mg: White, Round Tablet; Debossed WL on one side and 136 on the other side. Bottles of 90 tablets NDC 75826-136-90 Bottles of 100 tablets NDC 75826-136-10 Bottles of 500 tablets NDC 75826-136-50 Bottles of 1000 tablets NDC 75826-136-00 Phenobarbital Tablets, USP 16.2 mg (¼ grain): White, Round, Scored Tablet; Debossed WL on one side and 137 on the other side. Bottles of 90 tablets NDC 75826-137-90 Bottles of 100 tablets NDC 75826-137-10 Bottles of 500 tablets NDC 75826-137-50 Bottles of 1000 tablets NDC 75826-137-00 Phenobarbital Tablets, USP 30 mg: White, Round, Scored Tablet; Debossed WL on one side and 138 on the other side.

Bottles of 90 tablets NDC 75826-138-90 Bottles of 100 tablets NDC 75826-138-10 Bottles of 500 tablets NDC 75826-138-50 Bottles of 1000 tablets NDC 75826-138-00 Phenobarbital Tablets, USP 32.4 mg (½ grain): White, Round, Scored Tablet; Debossed WL on one side and 139 on the other side. Bottles of 90 tablets NDC 75826-139-90 Bottles of 100 tablets NDC 75826-139-10 Bottles of 500 tablets NDC 75826-139-50 Bottles of 1000 tablets NDC 75826-139-00 Phenobarbital Tablets, USP 60 mg: White, Round Tablet; Debossed WL on one side and 140 on the other side.

Bottles of 90 tablets NDC 75826-140-90 Bottles of 100 tablets NDC 75826-140-10 Bottles of 500 tablets NDC 75826-140-50 Bottles of 1000 tablets NDC 75826-140-00 Phenobarbital Tablets, USP 64.8 mg (1 grain): White, Round, Scored Tablet; Debossed WL on one side and 141 on the other side. Bottles of 90 tablets NDC 75826-141-90 Bottles of 100 tablets NDC 75826-141-10 Bottles of 500 tablets NDC 75826-141-50 Bottles of 1000 tablets NDC 75826-141-00 Phenobarbital Tablets, USP 97.2 mg (1½ grain): White, Round, Scored Tablet; Debossed WL on one side and 142 on the other side.

Bottles of 90 tablets NDC 75826-142-90 Bottles of 100 tablets NDC 75826-142-10 Bottles of 500 tablets NDC 75826-142-50 Bottles of 1000 tablets NDC 75826-142-00 Phenobarbital Tablets, USP 100 mg: White, Round, Scored Tablet; Debossed WL on one side and 143 on the other side. Bottles of 90 tablets NDC 75826-143-90 Bottles of 100 tablets NDC 75826-143-10 Bottles of 500 tablets NDC 75826-143-50 Bottles of 1000 tablets NDC 75826-143-00 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.

📦 Storage and Handling 33 words ▾

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 151 words ▾

DESCRIPTION The barbiturates are nonselective central nervous system (CNS) depressants primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act.

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, 16.2 mg, 30 mg, 32.4 mg, 60 mg, 64.8 mg, 97.2 mg, or 100 mg of phenobarbital, USP. Inactive ingredients are as follows: Microcrystalline Cellulose; Lactose Monohydrate; Sodium Starch Glycolate, Type-A; Colloidal Silicon Dioxide; Magnesium Stearate Chemical 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.