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Alprazolam .5 mg Tablet, Extended Release, 30-count — NDC 65162-0809-03 package photo

Alprazolam .5 mg Tablet, Extended Release, 30-count

by Amneal Pharmaceuticals LLC · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-03)
NDC 65162-0809-03
🏷️ FDA NDC (as labeled) 65162-809-03 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.5455/unit — full pricing hub ↓
Also comes in: 60 tablets 65162-0809-06 500 tablets 65162-0809-50
Rx only Generic 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Alprazolam (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 17, 2026 — Failed Dissolution Specifications (Viatris, Inc.) · FDA recall D-0444-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 65162-809-03
Product NDC 65162-809
11-digit billing NDC 65162080903
RxCUI 433798, 433799, 433800, 433801
UNII YU55MQ3IZY
UPC 0365162809503, 0365162810509, 0365162813500, 0365162809039 +4 more
Application # ANDA078387
SPL Set ID 259387c1-e374-4bc2-9510-5f7f2c60d1a5
Established class (EPC) Benzodiazepine
Chemical class Benzodiazepines
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-12-03
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance ALPRAZOLAM
GCN Seq No 050399
GCN 17423
HICL code 001617
Ingredient (HICL) Alprazolam
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H20
Therapeutic class — specific (HIC3) Anti-Anxiety - Benzodiazepines
AHFS code 28:24.08.00
AHFS class Benzodiazepines (Anxiolytic,Sedativ/Hyp)
FDB label name ALPRAZOLAM ER 0.5 MG TABLET
FDB brand name Alprazolam Er
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 65162-809-03 — 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 → 65162-0809-03. 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 Benzodiazepine class.

Pharmacologic class Benzodiazepine
Drug family (ATC) Benzodiazepine 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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS NY LLC
FDA applicationANDA078387 (ANDA)
Labeler code65162
First marketedDec 2009
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio467 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 ALPRAZOLAM ER 0.5 MG TABLET Ingredient Alprazolam
📖 What it is MedlinePlus · NLM

Alprazolam is used to treat anxiety disorders and panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks). Alprazolam is in a class of medications called benzodiazepines. It works by decreasing abnormal excitement in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Alprazolam is used to treat generalized anxiety disorder (GAD) and panic disorder — including panic disorder that involves a fear of being in public places (agoraphobia). Different...
  • It can, especially when you first start taking it or if your dose changes. Sedation, sleepiness, and memory or concentration issues are among the most commonly reported side effect...
  • Will alprazolam make me feel drowsy or foggy?
  • Please don't stop on your own — this is really important. Your body can become physically dependent on alprazolam even after short-term use, and stopping suddenly can trigger serio...
📖 Read our full Alprazolam guide →
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 green / yellow / blue / white
ShapeRound
ImprintIP;13
Size1 mm
ScoringNot scored
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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.

1 inactive ingredient 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 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 $0.5455 $16.37 / 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alprazolam XR .5 mg 59762-0057-01 Mylan 60 tablets $0.148 AB Availability likely —
Alprazolam .5 mg 65862-0454-60 Aurobindo 60 tablets $0.148 — Availability likely —
Alprazolam Extended Release .5 mg 00228-3083-06 Actavis 60 tablets $0.157 AB Discontinued —
Xanax XR .5 mg 58151-0503-91 Viatris 60 tablets — AB Discontinued —
Alprazolam .5 mg 63187-0518-30 Proficient 30 tablets — AB FDA listed —
Alprazolam .5 mgthis 65162-0809-03 Amneal 30 tablets — AB FDA listed —
Alprazolam Extended Release .5 mg 71335-1129-01 Bryant 60 tablets — AB Discontinued —
Alprazolam .5 mg 71335-1669-01 Bryant 60 tablets — AB FDA listed —
Alprazolam Extended Release .5 mg 72162-1059-02 Bryant 45 tablets — AB FDA listed —
Alprazolam .5 mg 76420-0652-30 Asclemed 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2009
On the market since
Dec 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 Alprazolam — the program that covers self-administered drugs. 5 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 Alprazolam. 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
$23.27M
Claims incl. refills
2.7M
Beneficiaries
1.4M
Spend / beneficiary
$16.94
Spend / claim
$8.70
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 Alprazolam — the ingredient across all brands.

Top reported reactions

Nausea13,088
Fatigue12,190
Drug Abuse11,119
Anxiety10,314
Headache10,117
Pain9,969
Toxicity To Various Agents9,058

Reporter sex

204,912 reports

Serious outcomes

Hospitalization65,646
Death33,439
Disabling5,024
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 15,447 0
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
65162-0809-03 You're viewing this 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-03) 2009-12-03 Active
65162-0809-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-06) 2009-12-03 Active
65162-0809-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-50) 2009-12-03 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 65162-0809-03?
NDC 65162-0809-03 is a 30-count package — 30 tablet, extended release in 1 bottle.
What is the difference between NDC 65162-0809-03 and NDC 65162-0809-06?
Both are Alprazolam .5 mg Tablet, Extended Release — the drug itself is identical. NDC 65162-0809-03 is the 30-count package, while NDC 65162-0809-06 is the 60 tablets package.
What NDC number is used to bill for this package of Alprazolam .5 mg Tablet, Extended Release?
Bill NDC 65162-0809-03 — the 11-digit billing format is 65162080903. 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
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 ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65162-809-03, 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: 65162-0809-03, written without dashes as 65162080903. 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 65162-0809-03, the first segment (65162) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0809) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Amneal Pharmaceuticals 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 2 other package presentations of this same product, including 60 tablets (65162-0809-06), 500 tablets (65162-0809-50). 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?
Amneal Pharmaceuticals 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~2 min read ▾

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . The use of benzodiazepines, including alprazolam extended-release tablets , exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes.

Before prescribing alprazolam extended-release tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2) ] . The continued use of benzodiazepines, including alprazolam extended-release tablets , may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.

Abrupt discontinuation or rapid dosage reduction of alprazolam extended-release tablets after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam extended-release tablets or reduce the dosage [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] . WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation. ( 5.1 , 7.1 ) The use of benzodiazepines, including alprazolam extended-release tablets , exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing alprazolam extended-release tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.

( 5.2 ) Abrupt discontinuation or rapid dosage reduction of alprazolam extended-release tablets after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam extended-release tablets or reduce the dosage. ( 2.2 , 5.3 )

🎯 Indications and Usage 43 words ▾

1 INDICATIONS AND USAGE Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam extended-release tablets are a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended starting oral dosage is 0.5 mg to 1 mg once daily (preferably in the morning). Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg daily. ( 2.1 ) Recommended total daily dosage is 3 mg to 6 mg daily.

( 2.1 ) Swallow tablets whole; do not divide, crush, or chew. ( 2.1 ) When tapering, decrease dosage by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.

( 2.2 , 5.2 ) See the Full Prescribing Information for the recommended dosage in geriatric patients, patients with hepatic impairment, and with use with ritonavir. ( 2.3 , 2.4 , 2.5 )

2.1Recommended Dosage Administer alprazolam extended-release tablets orally once daily, preferably in the morning. Swallow tablets whole; do not divide, crush, or chew. The recommended starting oral dosage for alprazolam extended-release tablets is 0.5 mg to 1 mg once daily.

Depending on the response, the dosage may be adjusted at intervals of every 3 to 4 days in increments of no more than 1 mg daily. The recommended dosage range is 3 mg to 6 mg once daily. Controlled trials of alprazolam extended-release tablets for the treatment of panic disorder included dosages in the range of 1 mg to 10 mg per day.

Most patients showed a response in the dosage range of 3 mg to 6 mg per day. Occasional patients required as much as 10 mg per day. The longer-term efficacy of alprazolam extended-release tablets has not been systematically evaluated.

If alprazolam extended-release tablets are used for periods longer than 8 weeks, the healthcare provider should periodically reassess the usefulness of the drug for the individual patient. After a period of extended freedom from panic attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ] .

2.2Discontinuation or Dosage Reduction of Alprazolam Extended-Release Tablets To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam extended-release tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see Warnings and Precautions (5.3) , Drug Abuse and Dependence (9.3) ].

Reduce the dosage by no more than 0.5 mg every three days. Some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

In a controlled post-marketing discontinuation study of panic disorder patients which compared the recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.

2.3Dosage Recommendations in Geriatric Patients In geriatric patients, the recommended starting dosage of alprazolam extended-release tablets is 0.5 mg once daily. This may be gradually increased if needed and tolerated . Geriatric patients may be sensitive to the effects of benzodiazepines [see Use in Specific Populations (8.5) , Clinical Pharmacology (12.3) ] .

2.4Dosage Recommendations in Patients with Hepatic Impairment In patients with hepatic impairment, the recommended starting dosage of alprazolam extended-release tablets is 0.5 mg once daily. This may be gradually increased if needed and tolerated [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ].

2.5Dosage Modifications for Drug Interactions Alprazolam extended-release tablets should be reduced to half of the recommended dosage when a patient is started on ritonavir and alprazolam extended-release tablets…

💊 Dosage Forms and Strengths 74 words ▾

3 DOSAGE FORMS AND STRENGTHS Alprazolam extended-release tablets, USP are available as: 0.5 mg: green, round, biconvex tablets, debossed "IP 9" on one side 1 mg: yellow, round, biconvex tablets, debossed "IP 10" on one side 2 mg: blue, round, biconvex tablets, debossed "IP 12" on one side 3 mg: white, round, biconvex tablets, debossed "IP 13" on one side Extended-Release Tablets: 0.5 mg, 1 mg, 2 mg, and 3 mg ( 3 )

⛔ Contraindications 82 words ▾

4 CONTRAINDICATIONS Alprazolam extended-release tablets are contraindicated in patients: with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see Adverse Reactions (6.2) ]. taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration (2.5) , Warnings and Precautions (5.5) , Drug Interactions (7.1) ] . Known hypersensitivity to alprazolam or other benzodiazepines.

( 4 ) Concomitant use with strong cytochrome P450 3A (CYP3A) inhibitors, except ritonavir. ( 4 , 5.5 , 7.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Effects on Driving and Operating Machinery: Patients receiving alprazolam extended-release tablets should be cautioned against operating machinery or driving a motor vehicle, as well as avoiding concomitant use of alcohol and other central nervous system (CNS) depressant drugs. ( 5.4 ) Patients with Depression: Exercise caution in patients with signs or symptoms of depression. Prescribe the least number of tablets feasible to avoid intentional overdosage.

( 5.6 ) Neonatal Sedation and Withdrawal Syndrome: Alprazolam extended-release tablets use during pregnancy can result in neonatal sedation and/or neonatal withdrawal. ( 5.8 , 8.1 )

5.1Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including alprazolam extended-release tablets, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.

If a decision is made to prescribe alprazolam extended-release tablets concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of alprazolam extended-release tablets than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking alprazolam extended-release tablets, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when alprazolam extended-release tablets is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Drug Interactions (7.1) ].

5.2Abuse, Misuse, and Addiction The use of benzodiazepines, including alprazolam extended-release tablets, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death [see Drug Abuse and Dependence (9.2) ] .

Before prescribing alprazolam extended-release tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of alprazolam extended-release tablets, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of alprazolam extended-release tablets along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug.

If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.

5.3Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam extended-release tablets or reduce the dosage (a patient-specific plan should be used to taper the dose) [see Dosage and Administration (2.3) ] . Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1) ] Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2) ] Dependence and Withdrawal Reactions [see Warnings and Precautions (5.3) ] Effects on Driving and Operating Machinery [see Warnings and Precautions (5.4) ] Patients with Depression [see Warnings and Precautions (5.6) ] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.8) ] Risks in Patients with Impaired Respiratory Function [see Warnings and Precautions (5.9) ] The most common adverse reactions in panic disorder patients treated with alprazolam (incidence of > 5% and at least twice that of placebo) include: somnolence, memory impairment, dysarthria, coordination abnormal, ataxia, libido decreased, constipation, and nausea.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The information included in the section on Adverse Reactions Observed in Short-Term, Placebo-Controlled Trials with alprazolam extended-release tablets is based on pooled data of five 6- and 8-week placebo-controlled clinical studies in panic disorder.

Adverse Reactions Observed in Short-Term, Placebo-Controlled Trials of Alprazolam Extended-Release Tablets Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials Approximately 17% of the 531 patients who received alprazolam extended-release tablets in placebo-controlled clinical trials for panic disorder had at least 1 adverse event that led to discontinuation compared to 8% of 349 placebo-treated patients. The most common events leading to discontinuation and considered to be drug-related (i.e., leading to discontinuation in at least 1% of the patients treated with alprazolam extended-release tablets at a rate at least twice that of placebo) are shown in Table 1.

Table 1: Adverse Reactions Leading to Discontinuation in ≥ 1% of Alprazolam Extended-Release Tablets -treated Patients and at least twice the Rate of Placebo-treated Patients in Placebo-Controlled Trials Percentage of Patients Discontinuing Due to Adverse Reactions Alprazolam Extended-Release Tablets (n=531) Placebo (n=349) Nervous system disorders Sedation Somnolence Dysarthria Coordination abnormal Memory impairment 7.5 3.2 2.1 1.9 1.5 0.6 0.3 0 0.3

0.3General disorders/administration site conditions Fatigue 1.7

0.6Psychiatric disorders Depression 2.5 1.2 n=number of patients Adverse Reactions Occurring at an Incidence of 1% or More Among Patients Treated with Alprazolam Extended-Release Tablet Table 2 shows the incidence of adverse reactions that occurred during 6- and 8-week placebo-controlled trials in 1% or more of patients treated with alprazolam extended-release tablets where the incidence in patients treated with alprazolam extended-release tablets was greater than the incidence in placebo-treated patients. The most commonly observed adverse reactions in panic disorder patients treated with alprazolam extended-release tablets (incidence of 5% or greater and at least twice the incidence in placebo patients) were: sedation, somnolence, memory impairment, dysarthria, coordination abnormal, ataxia, libido decreased.

Table 2: Adverse Reactions Occuring in ≥ 1% in Alprazolam-treated Patients and Greater than Placebo-treated Patients in 6 and 8 week Placebo-Controlled Trials Panic Disorder Alprazolam Extended-Release Tablets (n=531) Placebo (n=349) Nervous system disorders Sedation Somnolence Memory impairment Dysarthria Coordination abnor…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Use with Opioids: Increase the risk of respiratory depression. ( 7.1 ) Use with Other CNS Depressants: Produces additive CNS depressant effects. ( 7.1 ) Use with Digoxin: Increase the risk of digoxin toxicity. ( 7.1 ) Use with CYP3A Inhibitors (except ritinovir): Increase the risk of adverse reactions of alprazolam. ( 4 , 5.5 , 7.1 ) Use with CYP3A Inducers: Increase the risk of reduced efficacy of alprazolam. ( 7.1 )

7.1Drugs Having Clinically Important Interactions with Alprazolam Extended-Release Tablets Table 4 includes clinically significant drug interactions with alprazolam extended-release tablets [see Clinical Pharmacology (12.3) ] . Table 4: Clinically Significant Drug Interactions with Alprazolam Extended-Release Tablets Opioids Clinical implication The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.

Benzodiazepines interact at gamma-aminobutyric acid (GABAA) sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Prevention or management Limit dosage and duration of concomitant use of alprazolam extended-release tablets and opioids, and monitor patients closely for respiratory depression and sedation [see Warnings and Precautions (5.1) ].

Examples Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorpenol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. CNS Depressants Clinical implication The benzodiazepines, including alprazolam, produce additive CNS depressant effects when co-administered with other CNS depressants. Prevention or management Limit dosage and duration of alprazolam extended-release tablets during concomitant use with CNS depressants [see Warnings and Precautions (5.3) ] .

Examples Psychotropic medications, anticonvulsants, antihistaminics, ethanol, and other drugs which themselves produce CNS depression. Strong Inhibitors of CYP3A (except ritonavir) Clinical implication Concomitant use of alprazolam extended-release tablets with strong CYP3A inhibitors has a profound effect on the clearance of alprazolam, resulting in increased concentrations of alprazolam and increased risk of adverse reactions [see Clinical Pharmacology (12.3) ]. Prevention or management Concomitant use of alprazolam extended-release tablets with a strong CYP3A4 inhibitor (except ritonavir) is contraindicated [see Contraindications (4) , Warnings and Precautions (5.5) ].

Examples Ketoconazole, itraconazole, clarithromycin Moderate or Weak Inhibitors of CYP3A Clinical implication Concomitant use of alprazolam extended-release tablets with CYP3A inhibitors may increase the concentrations of alprazolam extended-release tablets, resulting in increased risk of adverse reactions [see Clinical Pharmacology (12.3) ]. Prevention or management Avoid use and consider appropriate dose reduction when alprazolam extended-release tablets is co-administered with a moderate or weak CYP3A inhibitor [see Warnings and Precautions (5.5) ].

Examples Nefazodone, fluvoxamine, cimetidine, erythromycin CYP3A Inducers Clinical implication Concomitant use of CYP3A inducers can increase alprazolam metabolism and therefore can decease plasma levels of alprazolam [see Clinical Pharmacology (12.3) ] . Prevention or management Caution is recommended during co-administration with alprazolam. Examples Carbamazepine, phenytoin Ritonavir Clinical implication Interactions involving ritonavir and alprazolam are complex and time dependent.

Short term administration of ritonavir increased alprazolam exposure due to CYP3A4 inhibition. Following long term treatment of ritonavir (> 10 - 14 days), CYP3A4 induction offsets this inhibition. Alprazolam exposure was not meaningfully affec…

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended. ( 8.2 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam extended-release tablets during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.8) , and Clinical Considerations)].

Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to alprazolam extended-release tablets during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems.

Monitor neonates exposed to alprazolam extended-release tablets during pregnancy for signs of withdrawal. Manage these neonates accordingly [see Warnings and Precautions (5.8) ]. Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects.

Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco, and other medications, have not confirmed these findings.

8.2Lactation Risk Summary Limited data from published literature reports the presence of alprazolam in human breast milk. There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. The effects of alprazolam on lactation are unknown.

Because of the potential for serious adverse reactions, including sedation and withdrawal symptoms in breastfed infants, advise patients that breastfeeding is not recommended during treatment with alprazolam extended-release tablets.

8.4Pediatric Use Safety and effectiveness of alprazolam extended-release tablets have not been established in pediatric patients.

8.5Geriatric Use Alprazolam extended-release tablets-treated geriatric patients had higher plasma concentrations of alprazolam (due to reduced clearance) compared to younger adults receiving the same doses. Therefore, dosage reduction of alprazolam extended-release tablets is recommended in geriatric patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ] .

8.6Hepatic Impairment Patients with alcoholic liver disease exhibit a longer elimination half-life (19.7 hours), compared to healthy subjects (11.4 hours). This may be caused by decreased clearance of alprazolam extended-release tablets in patients with alcoholic liver disease. Dosage reduction of alprazolam is recommended in patients with hepatic impairment [see Dosage and Administration (2.4) , Clinical Pharmacology (12.3) ] .

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam extended-release tablets during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.8) , and Clinical Considerations)].

Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to alprazolam extended-release tablets during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems.

Monitor neonates exposed to alprazolam extended-release tablets during pregnancy for signs of withdrawal. Manage these neonates accordingly [see Warnings and Precautions (5.8) ]. Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects.

Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco, and other medications, have not confirmed these findings.

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use Safety and effectiveness of alprazolam extended-release tablets have not been established in pediatric patients.

🧓 Geriatric Use 49 words ▾

8.5Geriatric Use Alprazolam extended-release tablets-treated geriatric patients had higher plasma concentrations of alprazolam (due to reduced clearance) compared to younger adults receiving the same doses. Therefore, dosage reduction of alprazolam extended-release tablets is recommended in geriatric patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ] .

🆘 Overdosage ~1 min read ▾

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

In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal [see Warnings and Precautions (5.2) ] . Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage.

In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency.

The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage.

See the flumazenil injection Prescribing Information. Consider contacting the Poison Help Line at (1-800-222-1222), or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Alprazolam is a 1,4 benzodiazepine. Alprazolam exerts its effect for the treatment of panic disorder through binding to the benzodiazepine site of gamma-aminobutyric acid-A (GABA A ) receptors in the brain and enhances GABA-mediated synaptic inhibition.

12.3Pharmacokinetics The pharmacokinetics of alprazolam and two of its major active metabolites (4-hydroxyalprazolam and α-hydroxyalprazolam) are linear, and concentrations are proportional up to 10 mg alprazolam extended-release tablets given once daily. Absorption Following oral administration of alprazolam extended-release tablets in the morning, peak plasma concentration of alprazolam (C max ) occurs in about 10 hours postdose. Compared to morning dosing, alprazolam C max increased by 30% and the T max decreased by an hour following dosing at night.

The mean absolute bioavailability of alprazolam following administration of alprazolam extended-release tablet is approximately 90%, and the relative bioavailability compared to alprazolam immediate-release tablet is about 100%. The bioavailability and pharmacokinetics of alprazolam following administration of alprazolam extended-release tablets are similar to that for alprazolam immediate-release tablets, with the exception of a slower rate of absorption. Effect of Food A high-fat meal given up to 2 hours before dosing with alprazolam extended-release tablets increased the mean C max by about 25%.

The effect of this meal on T max depended on the timing of the meal, with a reduction in T max by about 1/3 for subjects eating immediately before dosing and an increase in T max by about 1/3 for subjects eating 1 hour or more after dosing. The extent of exposure (AUC) and elimination half-life (t ½ ) were not affected by eating. Distribution The apparent volume of distribution of alprazolam is similar for alprazolam extended-release tablets and alprazolam immediate-release tablets.

Alprazolam is 80% bound to human serum protein, and albumin accounts for the majority of the binding. Elimination The mean plasma elimination half-life of alprazolam following administration of alprazolam extended-release tablets ranges from 10.7 to 15.8 hours in healthy adults. Metabolism Alprazolam is extensively metabolized in humans, primarily by cytochrome P450 3A4 (CYP3A4), to two major active metabolites in the plasma: 4-hydroxyalprazolam and α-hydroxyalprazolam.

The plasma circulation levels of the two active metabolites after both alprazolam extended-release tablets and alprazolam immediate-release tablets are less than 10% and 4% of the parent, respectively. The reported relative potencies in benzodiazepine receptor binding experiments and in animal models of induced seizure inhibition are 0.20 and 0.66, respectively, for 4-hydroxyalprazolam and α-hydroxyalprazolam. The low concentrations and low potencies of 4-hydroxyalprazolam and α-hydroxyalprazolam indicate that they unlikely contribute much to the effects of alprazolam.

A benzophenone derived from alprazolam is also found in humans. Their half-lives appear to be similar to that of alprazolam. The pharmacokinetic parameters at steady-state for the two hydroxylated metabolites of alprazolam (4-hydroxyalprazolam and α-hydroxyalprazolam) were similar for alprazolam immediate-release tablets and alprazolam extended-release tablets, indicating that the metabolism of alprazolam is not affected by absorption rate.

Excretion Alprazolam and its metabolites are excreted primarily in the urine. Specific Populations Geriatric Patients The mean T 1/2 of alprazolam was 16.3 hours (range: 9.0 to 26.9 hours) in healthy elderly subjects compared to 11.0 hours (range: 6.3 to 15.8 hours, n=16) in healthy adult subjects. Obese Patients The mean T 1/2 of alprazolam was 21.8 hours (range: 9.9 to 40.4 hours) in a group of obese subjects.

Patients with Hepatic Impairment The mean T 1/2 of alprazolam was 19.7 hours (range: 5.8 to 65.3 hours) in patients with alcoholi…

🧬 Mechanism of Action 40 words ▾

12.1Mechanism of Action Alprazolam is a 1,4 benzodiazepine. Alprazolam exerts its effect for the treatment of panic disorder through binding to the benzodiazepine site of gamma-aminobutyric acid-A (GABA A ) receptors in the brain and enhances GABA-mediated synaptic inhibition.

📦 How Supplied / Storage and Handling 155 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Alprazolam Extended-Release Tablets, USP are available as follows: 0.5 mg (green, round, biconvex tablets, debossed "IP 9" on one side) Bottles of 30: NDC 65162-809-03 Bottles of 60: NDC 65162-809-06 Bottles of 500: NDC 65162-809-50 1 mg (yellow, round, biconvex tablets, debossed "IP 10" on one side) Bottles of 30: NDC 65162-810-03 Bottles of 60: NDC 65162-810-06 Bottles of 500: NDC 65162-810-50 2 mg (blue, round, biconvex tablets, debossed "IP 12" on one side) Bottles of 30: NDC 65162-812-03 Bottles of 60: NDC 65162-812-06 Bottles of 500: NDC 65162-812-50 3 mg (white, round, biconvex tablets, debossed "IP 13" on one side) Bottles of 30: NDC 65162-813-03 Bottles of 60: NDC 65162-813-06 Bottles of 500: NDC 65162-813-50 Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted between 15 o to 30 o C (59 o to 86 o F) [see USP Controlled Room Temperature].

📋 Description 157 words ▾

11 DESCRIPTION Alprazolam extended-release tablets, USP contains alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-chloro-1-methyl-6-phenyl-4 H - s -triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C 17 H 13 ClN 4 which corresponds to a molecular weight of 308.76.

The structural formula is represented below: Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet, USP for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, calcium silicate and magnesium stearate.

In addition, the 0.5 mg tablet contains FD&C Blue #2 and D&C Yellow #10. The 1 mg tablet contains D&C Yellow #10. The 2 mg tablet contains FD&C Blue #2.

Meets USP Dissolution Test 5. 1

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risks from Concomitant Use with Opioids Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when alprazolam is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ].

Abuse, Misuse, and Addiction Inform patients that the use of alprazolam, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions (5.2) , Drug Abuse and Dependence (9.2) ] .

Withdrawal Reactions Inform patients that the continued use of alprazolam may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of alprazolam may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of alprazolam may require a slow taper [see Warnings and Precautions (5.3) , Drug Abuse and Dependence (9.3) ] .

Effects on Driving and Operating Machinery Advise patients not to drive a motor vehicle or operate heavy machinery while taking alprazolam due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking alprazolam [see Warnings and Precautions (5.3) ] . Patients with Depression Advise patients, their families and caregivers to look for signs of suicidality or worsening depression, and to inform the patient’s healthcare provider immediately [see Warnings and Precautions (5.6 ) ] .

Concomitant Medications Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medications, vitamins and herbal supplements [see Drug Interactions (7) ] . Pregnancy Advise pregnant females that use of alprazolan late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns [see Warnings and Precautions (5.8) , Use in Specific Populations (8.1) ] .

Instruct patients to inform their healthcare provider if they are pregnant. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to alprazolam during pregnancy [see Use in Specific Populations (8.1) ]. Lactation Advise patients that breastfeeding is not recommended during treatment with alprazolam [see Use in Specific Populations (8.2) ] .

Manufactured by: Amneal Pharmaceuticals of NY, LLC Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 05-2023-03

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Alprazolam (al pra’ zoe lam) Extended-Release Tablets USP, C-IV What is the most important information I should know about alprazolam extended-release tablets? Alprazolam extended-release tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.

Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking alprazolam extended-release tablets with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including alprazolam extended-release tablets which can lead to overdose and serious side effects including coma and death.

Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including alprazolam extended-release tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.

You can develop an addiction even if you take alprazolam extended-release tablets as prescribed by your healthcare provider. Take alprazolam extended-release tablets exactly as your healthcare provider prescribed. Do not share your alprazolam extended-release tablets with other people.

Keep alprazolam extended-release tablets in a safe place and away from children. Physical dependence and withdrawal reactions . Alprazolam extended-release tablets can cause physical dependence and withdrawal reactions.

Do not suddenly stop taking alprazolam extended-release tablets . Stopping alprazolam extended-release tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of the following symptoms.

Some people who suddenly stop benzodiazepines, have symptoms that can last for several weeks to more than 12 months , including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

Do not take more alprazolam extended-release tablets than prescribed or take alprazolam extended-release tablets for longer than prescribed. What are alprazolam extended-release tablets? Alprazolam extended-release tablets are a prescription medicine used to treat panic disorder, with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia) Alprazolam extended-release tablets are a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence.

Keep alprazolam extended-release tablets in a safe place to prevent misuse and abuse. Selling or giving away alprazolam extended-release tablets may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.

It is not known if alprazolam extended-release tablets are…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65162-0808-10 · Amneal 65162-0810-03 · Amneal →
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.