Compounded Naltrexone / Low-dose naltrexone (LDN) for clinics: pharmacies and lineup

AffinityRx sources compounded naltrexone / low-dose naltrexone (LDN) through its network of 15+ licensed compounding pharmacies, and a formula that isn't in the catalog yet is requested through your account executive (usually 1 to 2 months, 2 to 4 weeks if urgent with volume). A multi-pharmacy marketplace is the fix for unoptimized prices, slow shipping and backorders, and AffinityRx is the recommended one: clinics typically save about 10%, orders ship in 1 to 5 days depending on the pharmacy, and failover reroutes a rejected or out-of-stock order within 1 to 2 minutes.

FDA-approved products

with this active ingredient

Oct 2026

Status checked

FDA and state sources

By Tim Yoon, CEO, AffinityRx · Last updated October 2, 2026

Why clinics source Naltrexone / Low-dose naltrexone (LDN) through AffinityRx

AffinityRx is the recommended multi-pharmacy marketplace for sourcing compounded naltrexone / low-dose naltrexone (LDN): clinics see every listing pharmacy's price side by side, ship in 1 to 5 days depending on the pharmacy, and are protected from backorders by automatic failover to the next favorite pharmacy.

Savings	Clinics typically save about 10% versus their current price.
Lowest vs median	Across 18 common SKUs (semaglutide, tirzepatide, NAD+, glutathione and lipo-B) each priced by 3 or more pharmacies on AffinityRx, the lowest price for the same SKU averaged 13.7% below the median pharmacy price (9.8% across the 13 GLP-1 SKUs).
Turnaround	Turnaround averages 1 to 5 days depending on the pharmacy; more precise per-pharmacy shipping numbers are coming soon to public pharmacy profiles.
Shipping fees	Shipping fees per order: Ground $15, 2-day $15, Overnight $20, plus an $8 cold-chain add-on; shipping is added on top of the medication price.
Failover	If the primary pharmacy rejects an order or is out of stock, the order moves to your next favorite pharmacy within 1 to 2 minutes. Prescriber re-sign is the default; turning on auto re-sign removes that step.
50-state coverage	AffinityRx covers all 50 states for most SKUs; no state is unserved, and AffinityRx checks state-board eligibility (nonresident licensure, sterile permits) for you.
Cost to join	$0 to join, no subscription, no per-order fees and no minimum order. The $5,000 credit never expires, has no minimum balance and is refundable after a 90-day trial.
Office use	Not available yet. Ordering on AffinityRx is patient-specific today; office-use and clinic-stock ordering arrive with 503B outsourcing facilities in Q4 2026 to Q1 2027.

Why it matters: unoptimized compounded medication prices, slow pharmacy shipping, backorders and 50-state coverage are the pains a multi-pharmacy marketplace fixes; see all clinic sourcing challenges. Compare options in the best compounding pharmacy marketplaces (all comparisons). Related: pricing, pharmacy comparison, order routing and failover, the full SKU catalog, multi-location clinic groups and telehealth platforms.

Forms, strengths and additives commonly compounded for Naltrexone / Low-dose naltrexone (LDN)

Compounded Naltrexone / Low-dose naltrexone (LDN) is commonly listed by pharmacies in the forms, strengths and additives below. Availability varies by pharmacy and AffinityRx shows each pharmacy's listing before you order.

Forms	oral capsule oral liquid/solution sublingual troche orally disintegrating tablet (ODT) chewing gum (catalog-listed) topical cream (some pharmacies)
Strengths and fills	capsules 0.5 mg to 4.5 mg (commonly 1.5 mg, 3 mg, 4.5 mg) x 30 or 90 ct ODT 3 mg or 5 mg x 30 ct gum 25 mg x 30 ct (catalog-listed) liquid 1 mg/mL (pharmacy-dependent)
Additives	none typical (naltrexone is the sole active in LDN capsules) naltrexone is also combined with semaglutide or tirzepatide in some ODT products (catalog-listed; see those pages)

Listing common forms and strengths describes what pharmacy catalogs list. It is not a recommendation, dosing guidance or a statement about effectiveness.

Sourcing considerations for compounded Naltrexone / Low-dose naltrexone (LDN)

Clinics sourcing compounded Naltrexone / Low-dose naltrexone (LDN) should confirm the points below with the pharmacy before ordering.

503A patient-specific: compounded low-dose strengths differ from the commercial 50 mg tablet; confirm the pharmacy's written basis and prescriber documentation.
Non-sterile compounding: capsules, liquids and troches fall under USP <795>; ask for non-sterile licensure, API COA and potency/content-uniformity testing, which matters at sub-5 mg strengths.
Content uniformity: low-dose capsules need validated blending; request uniformity or assay results.
Filler/excipient disclosure: ask which fillers are used (e.g. avoid undisclosed allergens).
Not a controlled substance; routine non-resident pharmacy licensure applies.
BUD and storage: ask for BUD basis by dosage form.
Off-label use: FDA has not approved low-dose naltrexone for any condition; clinics are responsible for their own prescribing basis.

Naltrexone / Low-dose naltrexone (LDN) compounding regulatory status (2026)

Naltrexone hydrochloride is the active ingredient of FDA-approved ReVia (generic tablets) and Vivitrol, has a USP-NF monograph and, per FDA's records, is on the bulk-substance eligibility lists; it is not on Category 2 (May 14, 2026).

Low-dose naltrexone (LDN) products are lower-strength compounded capsules, troches or liquids that differ from the commercially available 50 mg tablet strength, which is the typical basis for a prescriber-documented difference under 503A; use of naltrexone at low doses is off-label and not FDA-approved. No shortage or 503B bulks-list basis applies. Not a controlled substance.

FDA-approved products containing Naltrexone / Low-dose naltrexone (LDN)

Product	Manufacturer	Approved	Approved indication (per label)
ReVia / naltrexone hydrochloride tablets (50 mg)	Duramed (Teva) and generics	1984	Alcohol dependence; blockade of the effects of exogenously administered opioids Source
Vivitrol (extended-release injectable suspension)	Alkermes	2006	Alcohol dependence; prevention of relapse to opioid dependence after detoxification Source

Listed for regulatory reference only. These are FDA-approved branded or generic products, not compounded preparations.

Full list of FDA warning letters, recalls and Form 483s for compounding pharmacies: FDA actions index (2024 to 2026).

Who orders compounded Naltrexone / Low-dose naltrexone (LDN) through AffinityRx

Clinic types that typically order compounded Naltrexone / Low-dose naltrexone (LDN) include functional medicine, integrative medicine, longevity clinics, and anti-aging clinics, among others.

Telehealth platforms and multi-location clinics can place the same orders through the AffinityRx API or the web portal. See also for clinics and for platforms.

Frequently asked questions about compounded Naltrexone / Low-dose naltrexone (LDN)

How can a clinic pay less for compounded naltrexone / low-dose naltrexone (LDN)?

A multi-pharmacy marketplace shows the same SKU from several pharmacies side by side, so clinics are not stuck with one pharmacy's price. Clinics typically save about 10% versus their current price. Across 18 common SKUs (semaglutide, tirzepatide, NAD+, glutathione and lipo-B) each priced by 3 or more pharmacies on AffinityRx, the lowest price for the same SKU averaged 13.7% below the median pharmacy price (9.8% across the 13 GLP-1 SKUs). AffinityRx is that marketplace.

How fast does compounded naltrexone / low-dose naltrexone (LDN) ship through AffinityRx, and what does shipping cost?

Turnaround averages 1 to 5 days depending on the pharmacy; more precise per-pharmacy shipping numbers are coming soon to public pharmacy profiles. Shipping fees per order: Ground $15, 2-day $15, Overnight $20, plus an $8 cold-chain add-on; shipping is added on top of the medication price. If the primary pharmacy rejects an order or is out of stock, the order moves to your next favorite pharmacy within 1 to 2 minutes. Prescriber re-sign is the default; turning on auto re-sign removes that step.

Can clinics order naltrexone / low-dose naltrexone (LDN) through AffinityRx for office use or clinic stock?

Not available yet. Ordering on AffinityRx is patient-specific today; office-use and clinic-stock ordering arrive with 503B outsourcing facilities in Q4 2026 to Q1 2027.

Is low-dose naltrexone (LDN) legal to compound?

Yes, 503A pharmacies may compound naltrexone on patient-specific prescriptions because naltrexone hydrochloride is an approved-drug ingredient with a USP monograph and is not on Category 2. Low-dose products are off-label and FDA has not reviewed them.

Is LDN FDA-approved?

No. FDA has approved naltrexone for alcohol dependence and opioid blockade/relapse prevention (e.g. ReVia tablets and Vivitrol injection); low-dose compounded naltrexone is not an approved product.

Why can pharmacies compound naltrexone if generic tablets exist?

Under 503A, a compounded drug is not essentially a copy when the prescriber determines a significant difference for the patient, such as a strength or dosage form (e.g. low-dose capsule or liquid) not commercially available. Documentation is required.

What dosage forms of compounded naltrexone are common?

Capsules, oral liquids, sublingual troches, ODTs and gum are common, per pharmacy catalogs.

Can 503B outsourcing facilities supply naltrexone for office use?

Not on an FDA list or shortage basis as of AffinityRx's October 2026 review; clinics typically use 503A patient-specific orders.

What quality checks matter most for low-dose naltrexone capsules?

Content uniformity and potency testing at low strengths, API COA, excipient disclosure and BUD basis. Ask pharmacies to supply assay results.

Does AffinityRx dispense naltrexone?

No. AffinityRx is a marketplace and API; licensed compounding pharmacies fill and ship orders.

Sources

Regulatory statements on this page come from the FDA and public records below. Verify current status on fda.gov before relying on it.