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Naltrexone Hydrochloride 50 mg Tablet, Film Coated, 120-count — NDC 71335-3104-05 package photo

Naltrexone Hydrochloride 50 mg Tablet, Film Coated, 120-count

by Bryant Ranch Prepack · 120 TABLET, FILM COATED in 1 BOTTLE (71335-3104-5)
NDC 71335-3104-05
🏷️ FDA NDC (as labeled) 71335-3104-5 billing pads the package segment with a zero
This package
Contains120-count Pack sizes7 compare ↓
Also priced by: Part D plans $1.49/unit — full pricing hub ↓
Also comes in: 15 tablets 71335-3104-06 30 tablets 71335-3104-01 45 tablets 71335-3104-04 60 tablets 71335-3104-03 90 tablets 71335-3104-02 100 tablets 71335-3104-07
Rx only Generic On market Non-controlled
🗂️ 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

🆔 Identity & classification

FDA NDC (as labeled) 71335-3104-5
Product NDC 71335-3104
11-digit billing NDC 71335310405
RxCUI 1483744
UNII Z6375YW9SF
Application # ANDA075274
SPL Set ID 7976b328-ad8e-4208-9f61-19cd5ab5f36b
Established class (EPC) Opioid Antagonist
Mechanism of action Opioid Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-09-23
Marketing end 2027-11-30
Route ORAL
Dosage form TABLET, FILM COATED
Substance NALTREXONE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71335-3104-5 — 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 → 71335-3104-05. 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 Opioid Antagonist class.

Pharmacologic class Opioid Antagonist
Drug family (ATC) Centrally acting antiobesity products, Natural opium alkaloids, Drugs used in alcohol dependence
How it works Opioid Antagonists
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

LabelerBryant Ranch Prepack
Application holderELITE LABORATORIES INC
FDA applicationANDA075274 (ANDA)
Labeler code71335
First marketedSep 2013
Product typeHuman Prescription Drug
Portfolio4,433 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

📖 What it is MedlinePlus · NLM

Naltrexone is used along with counseling and social support to help people who have stopped drinking alcohol and using street drugs continue to avoid drinking or using drugs. Naltrexone should not be used to treat people who are still using street drugs or drinking large amounts of alcohol. Naltrexone is in a class of medications called opiate antagonists. It works by decreasing the craving for alcohol and blocking the effects of opiate medications and opioid street drugs.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes — this is really important. You need to be completely free of opioids, including tramadol, for at least 7 to 10 days before your first dose or injection. If you start too soon,...
  • Do I have to stop my pain pills before starting naltrexone?
  • No. Naltrexone has no opioid-like effect on its own — it won't make you feel high or sedated. And if you're opioid-free when you start it, you won't feel withdrawal either. It's on...
  • Will naltrexone make me feel high or cause withdrawal if I'm not on opioids?
📖 Read our full Naltrexone 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 Yellow
ShapeRound
ImprintEL;15
Size1 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer 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 $1.49 $178.57 / 120 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
Naltrexone Hydrochloride 50 mg 51224-0206-30 TAGI 30 tablets $0.933 AB FDA listed —
Naltrexone Hydrochloride 50 mg 68094-0853-62 Precision 10 tablets $0.933 AB FDA listed —
Naltrexone Hydrochloride 50 mg 00406-1170-01 SpecGx 100 tablets $1.139 AB Availability likely —
Naltrexone Hydrochloride 50 mg 00904-7036-04 Major 1 tablet $1.139 AB Availability likely —
Naltrexone Hydrochloride 50 mg 16729-0081-01 Accord 100 tablets $1.139 AB Availability likely —
Naltrexone Hydrochloride 50 mg 23155-0886-01 Heritage 100 tablets $1.139 AB Availability likely —
Naltrexone Hydrochloride 50 mg 62135-0242-30 Chartwell 30 tablets $1.139 AB Availability likely —
Naltrexone Hydrochloride 50 mg 64850-0300-01 Elite 100 tablets $1.139 AB Availability likely —
Naltrexone Hydrochloride 50 mg 68084-0291-21 American 1 tablet $1.139 AB Availability likely —
Naltrexone Hydrochloride 50 mg 68094-0909-30 Precision 30 tablets $1.139 AB Availability likely —
Naltrexone Hydrochloride 50 mg 00615-8579-39 NCS 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 42291-0632-30 AvKARE 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 47335-0326-08 Sun 100 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 50090-4925-00 A-S 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 50090-6820-00 A-S 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 51407-0959-01 Golden 100 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 53401-0008-31 Aphena 600 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 63629-1047-01 Bryant 100 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 67046-0306-03 Coupler 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 68071-3654-03 NuCare 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 70518-2718-00 REMEDYREPACK 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 70518-4344-00 REMEDYREPACK 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-0014-01 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-1480-01 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-2062-01 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-2419-01 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-2480-01 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-2481-01 Bryant 100 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-2743-01 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-2987-01 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-3011-01 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-3012-01 Bryant 100 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-3039-01 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71335-3040-01 Bryant 100 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mgthis 71335-3104-05 Bryant 120 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71610-0919-31 Aphena 600 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 71610-0964-31 Aphena 600 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 72162-1566-01 Bryant 100 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 72162-2154-03 Bryant 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 72162-2311-01 Bryant 100 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 72162-2529-01 Bryant 100 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 82804-0199-30 Proficient 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 67046-0060-03 Coupler 30 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 67296-2282-09 Redpharm 90 tablets — AB FDA listed —
Naltrexone Hydrochloride 50 mg 53401-0023-30 Aphena 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

🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71335-3104-01 30 TABLET, FILM COATED in 1 BOTTLE (71335-3104-1) 2026-03-16 Active
71335-3104-02 90 TABLET, FILM COATED in 1 BOTTLE (71335-3104-2) 2026-03-16 Active
71335-3104-03 60 TABLET, FILM COATED in 1 BOTTLE (71335-3104-3) 2026-03-16 Active
71335-3104-04 45 TABLET, FILM COATED in 1 BOTTLE (71335-3104-4) 2026-03-16 Active
71335-3104-05 You're viewing this 120 TABLET, FILM COATED in 1 BOTTLE (71335-3104-5) 2026-03-16 Active
71335-3104-06 15 TABLET, FILM COATED in 1 BOTTLE (71335-3104-6) 2026-03-16 Active
71335-3104-07 100 TABLET, FILM COATED in 1 BOTTLE (71335-3104-7) 2026-03-16 Active

You're viewing the largest of 7 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-3104-05?
NDC 71335-3104-05 is a 120-count package — 120 tablet, film coated in 1 bottle.
What is the difference between NDC 71335-3104-05 and NDC 71335-3104-06?
Both are Naltrexone Hydrochloride 50 mg Tablet, Film Coated — the drug itself is identical. NDC 71335-3104-05 is the 120-count package, while NDC 71335-3104-06 is the 15 tablets package.
What NDC number is used to bill for this package of Naltrexone Hydrochloride 50 mg Tablet, Film Coated?
Bill NDC 71335-3104-05 — the 11-digit billing format is 71335310405. 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 71335-3104-5, 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: 71335-3104-05, written without dashes as 71335310405. 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 71335-3104-05, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (3104) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 it is currently marketed — but Bryant Ranch Prepack has reported a marketing end date of 2027-11-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 15 tablets (71335-3104-06), 30 tablets (71335-3104-01), 45 tablets (71335-3104-04). 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?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 51 words ▾

INDICATIONS AND USAGE Naltrexone Hydrochloride Tablets USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone Hydrochloride Tablets USP have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION To reduce the risk of precipitated withdrawal in patients dependent on opioids, or exacerbation of a preexisting subclinical withdrawal syndrome, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting naltrexone hydrochloride tablets treatment. An opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids. Switching from Buprenorphine, Buprenorphine/Naloxone, or Methadone There are no systematically collected data that specifically address the switch from buprenorphine or methadone to naltrexone hydrochloride tablets; however, review of postmarketing case reports have indicated that some patients may experience severe manifestations of precipitated withdrawal when being switched from opioid agonist therapy to opioid antagonist therapy (see WARNINGS ).

Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as 2 weeks. Healthcare providers should be prepared to manage withdrawal symptomatically with non-opioid medications. Treatment of Alcoholism A dose of 50 mg once daily is recommended for most patients.

The placebo-controlled studies that demonstrated the efficacy of naltrexone hydrochloride as an adjunctive treatment of alcoholism used a dose regimen of naltrexone hydrochloride 50 mg once daily for up to 12 weeks. Other dose regimens or durations of therapy were not evaluated in these trials. Naltrexone hydrochloride tablets should be considered as only one of many factors determining the success of treatment of alcoholism.

Factors associated with a good outcome in the clinical trials with naltrexone hydrochloride tablets were the type, intensity, and duration of treatment; appropriate management of comorbid conditions; use of community-based support groups; and good medication compliance. To achieve the best possible treatment outcome, appropriate compliance-enhancing techniques should be implemented for all components of the treatment program, especially medication compliance. Treatment of Opioid Dependence Treatment should be initiated with an initial dose of 25 mg of naltrexone hydrochloride tablets.

If no withdrawal signs occur, the patient may be started on 50 mg a day thereafter. A dose of 50 mg once a day will produce adequate clinical blockade of the actions of parenterally administered opioids. As with many non-agonist treatments for addiction, naltrexone hydrochloride tablets are of proven value only when given as part of a comprehensive plan of management that includes some measure to ensure the patient takes the medication.

Naloxone Challenge Test Clinicians are reminded that there is no completely reliable method for determining whether a patient has had an adequate opioid-free period. A naloxone challenge test may be helpful if there is any question of occult opioid dependence. If signs of opioid withdrawal are still observed following naloxone challenge, treatment with naltrexone hydrochloride tablets should not be attempted.

The naloxone challenge can be repeated in 24 hours. The naloxone challenge test should not be performed in a patient showing clinical signs or symptoms of opioid withdrawal, or in a patient whose urine contains opioids. The naloxone challenge test may be administered by either the intravenous or subcutaneous routes.

Intravenous Inject 0.2 mg naloxone. Observe for 20 minutes for signs or symptoms of withdrawal. If no evidence of withdrawal, inject 0.6 mg of naloxone.

Observe for an additional 20 minutes. Subcutaneous Administer 0.8 mg naloxone. Observe for 20 minutes for signs or symptoms of withdrawal.

Note: Individual patients, especially those with opioid dependence, may respond to lower doses of naloxone. In some cases, 0.1 mg IV naloxone has produced a diagnostic response. Interpretation of the Challenge Monitor vital signs and observe the pat…

⛔ Contraindications 88 words ▾

CONTRAINDICATIONS Naltrexone hydrochloride is contraindicated in: Patients receiving opioid analgesics. Patients currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine). Patients in acute opioid withdrawal (see WARNINGS ).

Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids. Any individual with a history of sensitivity to naltrexone hydrochloride or any other components of this product. It is not known if there is any cross-sensitivity with naloxone or the phenanthrene containing opioids.

⚠️ Warnings ~3 min read ▾

WARNINGS Vulnerability to Opioid Overdose After opioid detoxification, patients are likely to have reduced tolerance to opioids. As the blockade of exogenous opioids provided by naltrexone hydrochloride wanes and eventually dissipates completely, patients who have been treated with naltrexone hydrochloride may respond to lower doses of opioids than previously used, just as they would shortly after completing detoxification. This could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.) if the patient uses previously tolerated doses of opioids.

Cases of opioid overdose with fatal outcomes have been reported in patients after discontinuing treatment. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after naltrexone hydrochloride treatment is discontinued. It is important that patients inform family members, and the people closest to the patient of this increased sensitivity ot opioids and the risk of overdose (see PRECATIONS, Information for Patients ).

There is also the possibility that a patient who is treated with naltrexone hydrochloride could overcome the opioid blockade effect of naltrexone hydrochloride. Although naltrexone hydrochloride is a potent antagonist, the blockade produced by naltrexone hydrochloride is surmountable. The plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade.

This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids. Any attempt by a patient to overcome the antagonism by taking opioids is especially dangerous and may lead to life-threatening opioid intoxication or fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade (see PRECAUTIONS, Information for Patients ).

Precipitated Opioid Withdrawal The symptoms of spontaneous opioid withdrawal (which are associated with the discontinuation of opioid in a dependent individual) are uncomfortable, but they are not generally believed to be severe or necessitate hospitalization. However, when withdrawal is precipitated abruptly by the administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe enough to require hospitalization. Symptoms of withdrawal have usually appeared within five minutes of ingestion of naltrexone hydrochloride and have lasted for up to 48 hours.

Mental status changes including confusion, somnolence and visual hallucinations have occurred. Significant fluid losses from vomiting and diarrhea have required intravenous fluid administration. Review of postmarketing cases of precipitated opioid withdrawal in association with naltrexone treatment has identified cases with symptoms of withdrawal severe enough to require hospital admission, and in some cases, management in the intensive care unit.

To prevent occurrence of precipitated withdrawal in patients dependent on opioids, or exacerbation of a pre-existing subclinical withdrawal syndrome, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting naltrexone hydrochloride treatment. An opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks.

If a more rapid transition from agonist to antagonist therapy is deemed necessary and appropriate by the healthcare provider, monitor the patient closely in an appropriate medical setting where precipitated withdrawal can be managed. In every case, healthcare providers should always be prepared to manage withdrawal symptomatically with non-opioid medic…

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS During two randomized, double-blind placebo-controlled 12-week trials to evaluate the efficacy of naltrexone hydrochloride as an adjunctive treatment of alcohol dependence, most patients tolerated naltrexone hydrochloride well. In these studies, a total of 93 patients received naltrexone hydrochloride at a dose of 50 mg once daily. Five of these patients discontinued naltrexone hydrochloride because of nausea.

No serious adverse events were reported during these two trials. While extensive clinical studies evaluating the use of naltrexone hydrochloride in detoxified, formerly opioid-dependent individuals failed to identify any single, serious untoward risk of naltrexone hydrochloride use, placebo-controlled studies employing up to five fold higher doses of naltrexone hydrochloride (up to 300 mg per day) than that recommended for use in opiate receptor blockade have shown that naltrexone hydrochloride causes hepatocellular injury in a substantial proportion of patients exposed at higher doses (see WARNINGS and PRECAUTIONS, Laboratory Tests ).

Aside from this finding, and the risk of precipitated opioid withdrawal, available evidence does not incriminate naltrexone hydrochloride, used at any dose, as a cause of any other serious adverse reaction for the patient who is "opioid-free." It is critical to recognize that naltrexone hydrochloride can precipitate or exacerbate abstinence signs and symptoms in any individual who is not completely free of exogenous opioids. Patients with addictive disorders, especially opioid addiction, are at risk for multiple numerous adverse events and abnormal laboratory findings, including liver function abnormalities .

Data from both controlled and observational studies suggest that these abnormalities, other than the dose-related hepatotoxicity described above, are not related to the use of naltrexone hydrochloride. Among opioid-free individuals, naltrexone hydrochloride administration at the recommended dose has not been associated with a predictable profile of serious adverse or untoward events. However, as mentioned above, among individuals using opioids, naltrexone hydrochloride may cause serious withdrawal reactions (see CONTRAINDICATIONS , WARNINGS , DOSAGE AND ADMINISTRATION ).

Reported Adverse Events Naltrexone hydrochloride has not been shown to cause significant increases in complaints in placebo-controlled trials in patients known to be free of opioids for more than 7 to 10 days. Studies in alcoholic populations and in volunteers in clinical pharmacology studies have suggested that a small fraction of patients may experience an opioid withdrawal-like symptom complex consisting of tearfulness, mild nausea, abdominal cramps, restlessness, bone or joint pain, myalgia, and nasal symptoms. This may represent the unmasking of occult opioid use, or it may represent symptoms attributable to naltrexone.

A number of alternative dosing patterns have been recommended to try to reduce the frequency of these complaints. Alcoholism In an open label safety study with approximately 570 individuals with alcoholism receiving naltrexone hydrochloride, the following new-onset adverse reactions occurred in 2% or more of the patients: nausea (10%), headache (7%), dizziness (4%), nervousness (4%), fatigue (4%), insomnia (3%), vomiting (3%), anxiety (2%) and somnolence (2%). Depression, suicidal ideation, and suicidal attempts have been reported in all groups when comparing naltrexone, placebo, or controls undergoing treatment for alcoholism.

RATE RANGES OF NEW ONSET EVENTS Naltrexone Placebo Depression 0 to 15% 0 to 17% Suicide Attempt/Ideation 0 to 1% 0 to 3% Although no causal relationship with naltrexone hydrochloride is suspected, physicians should be aware that treatment with naltrexone does not reduce the risk of suicide in these patients (see PRECAUTIONS ). Opioid Addiction The following adverse reactions have been reported both at baseline and during the naltrexone hydrochloride clinic…

🔄 Drug Interactions 145 words ▾

Drug Interactions Studies to evaluate possible interactions between naltrexone hydrochloride and drugs other than opiates have not been performed. Consequently, caution is advised if the concomitant administration of naltrexone hydrochloride and other drugs is required. The safety and efficacy of concomitant use of naltrexone hydrochloride and disulfiram is unknown, and the concomitant use of two potentially hepatotoxic medications is not ordinarily recommended unless the probable benefits outweigh the known risks.

Lethargy and somnolence have been reported following doses of naltrexone hydrochloride and thioridazine. Patients taking naltrexone hydrochloride may not benefit from opioid containing medicines, such as cough and cold preparations, antidiarrheal preparations, and opioid analgesics. In an emergency situation when opioid analgesia must be administered to a patient receiving naltrexone hydrochloride, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged (see PRECAUTIONS ).

🤰 Pregnancy 157 words ▾

Pregnancy Teratogenic Effects Category C Naltrexone has been shown to increase the incidence of early fetal loss when given to rats at doses ≥30 mg/kg/day (180 mg/m 2 /day; 5 times the recommended therapeutic dose, based on body surface area) and to rabbits at oral doses ≥60 mg/kg/day (720 mg/m 2 /day; 18 times the recommended therapeutic dose, based on body surface area). There was no evidence of teratogenicity when naltrexone was administered orally to rats and rabbits during the period of major organogenesis at doses up to 200 mg/kg/day (32 and 65 times the recommended therapeutic dose, respectively, based on body surface area).

Rats do not form appreciable quantities of the major human metabolite, 6-β-naltrexol; therefore, the potential reproductive toxicity of the metabolites in rats is not known. There are no adequate and well-controlled studies in pregnant women. Naltrexone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 20 words ▾

Pediatric Use The safe use of naltrexone hydrochloride in pediatric patients younger than 18 years old has not been established.

🆘 Overdosage 128 words ▾

OVERDOSAGE There is limited clinical experience with naltrexone hydrochloride overdosage in humans. In one study, subjects who received 800 mg daily of naltrexone hydrochloride for up to one week showed no evidence of toxicity. In the mouse, rat and guinea pig, the oral LD50s were 1,100 to 1,550 mg/kg; 1,450 mg/kg; and 1,490 mg/kg; respectively.

High doses of naltrexone hydrochloride (generally ÿ1,000 mg/kg) produced salivation, depression/reduced activity, tremors, and convulsions. Mortalities in animals due to high-dose naltrexone hydrochloride administration usually were due to clonic-tonic convulsions and/or respiratory failure. Treatment of Overdosage In view of the lack of actual experience in the treatment of naltrexone hydrochloride overdose, patients should be treated symptomatically in a closely supervised environment.

Physicians should contact a poison control center for the most up-to-date information.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamic Actions Naltrexone hydrochloride is a pure opioid antagonist. It markedly attenuates or completely blocks, reversibly, the subjective effects of intravenously administered opioids. When co-administered with morphine, on a chronic basis, naltrexone hydrochloride blocks the physical dependence to morphine, heroin and other opioids.

Naltrexone hydrochloride has few, if any, intrinsic actions besides its opioid blocking properties. However, it does produce some pupillary constriction, by an unknown mechanism. The administration of naltrexone hydrochloride is not associated with the development of tolerance or dependence.

In subjects physically dependent on opioids, naltrexone hydrochloride will precipitate withdrawal symptomatology. Clinical studies indicate that 50 mg of naltrexone hydrochloride will block the pharmacologic effects of 25 mg of intravenously administered heroin for periods as long as 24 hours. Other data suggest that doubling the dose of naltrexone hydrochloride provides blockade for 48 hours, and tripling the dose of naltrexone hydrochloride provides blockade for about 72 hours.

Naltrexone hydrochloride blocks the effects of opioids by competitive binding (i.e., analogous to competitive inhibition of enzymes) at opioid receptors. This makes the blockade produced potentially surmountable, but overcoming full naltrexone blockade by administration of very high doses of opiates has resulted in excessive symptoms of histamine release in experimental subjects. The mechanism of action of naltrexone hydrochloride in alcoholism is not understood; however, involvement of the endogenous opioid system is suggested by preclinical data.

Naltrexone, an opioid receptor antagonist, competitively binds to such receptors and may block the effects of endogenous opioids. Opioid antagonists have been shown to reduce alcohol consumption by animals, and naltrexone hydrochloride has been shown to reduce alcohol consumption in clinical studies. Naltrexone hydrochloride is not aversive therapy and does not cause a disulfiram-like reaction either as a result of opiate use or ethanol ingestion.

Pharmacokinetics Naltrexone hydrochloride is a pure opioid receptor antagonist. Although well absorbed orally, naltrexone is subject to significant first pass metabolism with oral bioavailability estimates ranging from 5 to 40%. The activity of naltrexone is believed to be due to both parent and the 6-β-naltrexol metabolite.

Both parent drug and metabolites are excreted primarily by the kidney (53% to 79% of the dose), however, urinary excretion of unchanged naltrexone accounts for less than 2% of an oral dose and fecal excretion is a minor elimination pathway. The mean elimination half-life (T-1/2) values for naltrexone and 6-β-naltrexol are 4 hours and 13 hours, respectively. Naltrexone and 6-β-naltrexol are dose proportional in terms of AUC and C max over the range of 50 to 200 mg and do not accumulate after 100 mg daily doses.

Absorption Following oral administration, naltrexone undergoes rapid and nearly complete absorption with approximately 96% of the dose absorbed from the gastrointestinal tract. Peak plasma levels of both naltrexone and 6-β-naltrexol occur within one hour of dosing. Distribution The volume of distribution for naltrexone following intravenous administration is estimated to be 1350 liters.

In vitro tests with human plasma show naltrexone to be 21% bound to plasma proteins over the therapeutic dose range. Metabolism The systemic clearance (after intravenous administration) of naltrexone is ~3.5 L/min, which exceeds liver blood flow (~1.2 L/min). This suggests both that naltrexone is a highly extracted drug (>98% metabolized) and that extra hepatic sites of drug metabolism exist.

The major metabolite of naltrexone is 6-β-naltrexol. Two other minor metabolites are 2-hydroxy-3-methoxy-6-β-naltrexol and 2-hydroxy-3-methyl-naltrexone. Naltrexone and its metabolites are also conjugated to form add…

📦 How Supplied / Storage and Handling 144 words ▾

HOW SUPPLIED Naltrexone Hydrochloride Tablets, USP are available as: 50 mg; yellow, round film-coated tablets, bisected on one side, debossed with "EL" on one side of the bisect and "15" on the other side of the bisect. They are available in bottles of: NDC 71335-3104-1: 30 Tablets in a BOTTLE NDC 71335-3104-2: 90 Tablets in a BOTTLE NDC 71335-3104-3: 60 Tablets in a BOTTLE NDC 71335-3104-4: 45 Tablets in a BOTTLE NDC 71335-3104-5: 120 Tablets in a BOTTLE NDC 71335-3104-6: 15 Tablets in a BOTTLE NDC 71335-3104-7: 100 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 146 words ▾

DESCRIPTION Naltrexone hydrochloride, an opioid antagonist, are a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone.

The chemical name for naltrexone hydrochloride is Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, hydrochloride, (5a)-. The structural formula is as follows: C 20 H 23 NO 4 ∙HCl Molecular Weight: 377.86 Naltrexone hydrochloride is a white, crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL.

Naltrexone Hydrochloride Tablets USP are available in scored film-coated tablets containing 50 mg of naltrexone hydrochloride. Naltrexone Hydrochloride Tablets USP also contain: carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and yellow iron oxide.

💬 Information for Patients ~3 min read ▾

Information for Patients It is recommended that the prescribing physician relate the following information to patients being treated with naltrexone hydrochloride: You have been prescribed naltrexone hydrochloride as part of the comprehensive treatment for your alcoholism or drug dependence. You should carry identification to alert medical personnel to the fact that you are taking naltrexone hydrochloride. A naltrexone hydrochloride medication card may be obtained from your physician and can be used for this purpose.

Carrying the identification card should help to ensure that you can obtain adequate treatment in an emergency. If you require medical treatment, be sure to tell the treating physician that you are receiving naltrexone hydrochloride therapy. You should take naltrexone hydrochloride as directed by your physician.

Advise patients that if they previously used opioids, they may be more sensitive to lower doses of opioids and at risk of accidental overdose should they use opioids after naltrexone hydrochloride treatment is discontinued or temporarily interrupted. It is important that patients inform family members and the people closest to the patient of this increased sensitivity to opioids and the risk of overdose. Advise patients that because naltrexone hydrochloride can block the effects of opioids, patients will not perceive any effect if they attempt to self-administer heroin or any other opioid drug in small doses while on naltrexone hydrochloride.

Further, emphasize that administration of large doses of heroin or any other opioid to try to bypass the blockade and get high while on naltrexone hydrochloride may lead to serious injury, coma or death. Patients on naltrexone hydrochloride may not experience the expected effects from opioid-containing analgesic, antidiarrheal, or antitussive medications. Patients should be off all opioids, including opioid-containing medicines, for a minimum or 7 to 10 days before starting naltrexone hydrochloride in order to avoid precipitation of opioid withdrawal.

Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks. Ensure that patients understand that withdrawal precipitated by administration of an opioid antagonist may be severe enough to require hospitalization if they have not been opioid-free for an adequate period of time, and is different from the experience of spontaneous withdrawal that occurs with discontinuation of opioid in a dependent individual. Advise patients that they should not take naltrexone hydrochloride if they have symptoms of opioid withdrawal.

Advise all patients, including those with alcohol dependence, that it is imperative to notify healthcare providers of any recent use of opioids or any history of opioid dependence before starting naltrexone hydrochloride to avoid precipitation of opioid withdrawal. Advise patients that naltrexone hydrochloride may cause liver injury. Patients should immediately notify their physician if they develop symptoms and/or signs of liver disease.

Advise patients that they may experience depression while taking naltrexone hydrochloride. It is important that patients inform family members and the people closest to the patient that they are taking naltrexone hydrochloride and that they should call a doctor right way should they become depressed or experience symptoms of depression. Advise patients that naltrexone hydrochloride has been shown to be effective only when used as part of a treatment program that includes counseling and support.

Advise patients that dizziness may occur with naltrexone hydrochloride treatment, and they should avoid driving or operating heavy machinery until they have determined how naltrexone hydrochloride affects them. Advise patients to notify their physician if they: become pregnant or intend to become pregnant during treatment with naltrexone hydrochloride. are breastfeeding. experience other unusual or significan…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-3103-00 · Bryant 71335-3105-01 · Bryant →
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.