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Phenobarbital 64.8 mg Tablet, 30-count — NDC 67046-1434-3 (Billing 67046-1434-03)

by Coupler LLC · 30 TABLET in 1 BLISTER PACK

This is a package of 30 tablets of Phenobarbital 64.8 mg Tablet from Coupler LLC, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 67046-1434-03
🏷️ FDA NDC (as labeled) 67046-1434-3 billing pads the package segment with a zero
Rx only 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67046-1434-3
Product NDC 67046-1434
11-digit billing NDC 67046143403
RxCUI 199168
UNII YQE403BP4D
SPL Set ID 38f738a5-1c2f-b404-e063-6294a90a9879
DEA schedule CIV
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-02
Route ORAL
Dosage form TABLET
Substance PHENOBARBITAL
Quick answers
  • RxCUI (RxNorm): 199168
Why two NDCs? The FDA registers this code as 67046-1434-3 — a 5-4-1 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 package segment → 67046-1434-03. 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

📗 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 →
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 · Q2 2026 $0.4289 $12.87 / 30 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
67046-1434-03 You're viewing this Main listing 30 TABLET in 1 BLISTER PACK 2025-07-02 — Active

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 mg 75826-0141-00 WINDER 1000 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 mgthis 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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.

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerCoupler LLC
Labeler code67046
First marketedJul 2025
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio465 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full 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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 📄 Package Label / Principal Display Panel
🎯 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 149 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

💬 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.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Precautions Barbiturates induce liver microsomal enzyme activity. This accelerates the biotransformation of various drugs and is probably part of the mechanism of the tolerance encountered with barbiturates. Phenobarbital, therefore, should be used with caution in patients with decreased liver function.

This drug should also be administered cautiously to patients with a history of drug dependence or abuse (see DRUG ABUSE AND DEPENDENCE ). Phenobarbital may decrease the potency of coumarin anticoagulants; therefore, patients receiving such concomitant therapy should have more frequent prothrombin determinations. As with other sedatives and hypnotics, elderly or debilitated patients may react to barbiturates with marked excitement, depression, or confusion.

The systemic effects of exogenous hydrocortisone and endogenous hydrocortisone (cortisol) may be diminished by phenobarbital. Thus, this product should be administered with caution to patients with borderline hypoadrenal function, regardless of whether it is of pituitary or of primary adrenal origin. 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. 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 ). 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 . Nursing Mothers Caution should be exercised when phenobarbital is administered to a nursing woman.

🍼 Nursing Mothers 14 words ▾

Nursing Mothers Caution should be exercised when phenobarbital is administered to a nursing woman.

🔒 Drug Abuse and Dependence 53 words ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance Phenobarbital is a Schedule IV drug. Dependence Prolonged, uninterrupted use of barbiturates (particularly the short-acting drugs), even in therapeutic doses, may result in psychic and physical dependence. Withdrawal symptoms due to physical dependence following chronic use of large doses of barbiturates may include delirium, convulsions, and death.

🔒 Controlled Substance 8 words ▾

Controlled Substance Phenobarbital is a Schedule IV drug.

📄 Package Label / Principal Display Panel 1 words ▾

label

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

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

Medicare Part D (outpatient prescription) spending for 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.

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

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "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 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 Coupler LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Coupler 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.
← 67046-1433-03 · Coupler 67046-1440-03 · Coupler →
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.