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dolophine hydrochloride

Pharmaranks rates Dolophine Hydrochloride 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Dolophine Hydrochloride (Methadone Hydrochloride) is an opioid agonist used to treat Opioid-Related Disorders, Intractable Pain.

Methadone Hydrochloride · by Hikma

Available as a generic: Methadone Hydrochloride

72/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 20, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass
Lower-cost optionsSave up to 70%
This medication~$0.18
Cheapest in class · imodium a-d~$0.05
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Key facts

Active ingredient
Methadone Hydrochloride
Drug class
Opioid Agonist
Form
Tablet, Syrup
Strength
Methadone Hydrochloride 10MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Methadone Hydrochloride 10MG/30ML · Methadone Hydrochloride 5MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
Type
Prescription (Rx)
Brand or generic
Brand-name
Manufacturer
Hikma
Half-life
about 8 to 59 hours (terminal/elimination half-life; a very wide range) (how long it stays in your system)
What the pharmacy pays
~$0.18 per ml — not your price
FDA application
NDA006134
Availability
Discontinued (per FDA)

How long does Methadone Hydrochloride stay in your body?

The elimination half-life of methadone hydrochloride is about 8 to 59 hours (terminal/elimination half-life; a very wide range) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) half-life after a single IV dose, distinct from the distribution phase. Methadone's only metabolite, EDDP, is explicitly INACTIVE per the label, so there is no active metabolite that outlasts the parent. However, methadone persists in the liver and other tissues and is released slowly, so its clinical duration of action can outlast plasma levels even though the number itself is a plasma half-life. Population effects the label names: the terminal half-life DECREASES during the 2nd/3rd trimesters of pregnancy (clearance rises), which can cause withdrawal. In hepatic impairment, methadone may ACCUMULATE with repeated dosing (metabolized in the liver), though PK was not extensively studied. In renal impairment, unchanged drug and metabolites are excreted to a variable degree and urine acidity affects elimination, but no half-life change is quantified. The label states methadone PK has NOT been evaluated in geriatric or pediatric populations.

This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Methadone Hydrochloride Injection label — DailyMed (Clinical Pharmacology, Pharmacokinetics: Excretion).

Drug class

How this class works, per Mu Receptors - StatPearls - NCBI Bookshelf.

May treat (source: NIH RxClass)

See how Dolophine Hydrochloride ranks — best-rated opioid agonist for:

Dosage forms

Tablet and Syrup

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

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Request a 90-day supply

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Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

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Frequently asked questions

What does Dolophine Hydrochloride treat?
Dolophine Hydrochloride (Methadone Hydrochloride) may be used to treat opioid-related disorders, intractable pain, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How does Dolophine Hydrochloride work?
Dolophine Hydrochloride is a opioid agonist. Opioid agonists bind opioid receptors (mainly mu receptors) on nerves in the brain and spinal cord, dampening the release of pain-signaling chemicals so fewer pain messages reach the brain, which relieves moderate to severe pain.
How is Dolophine Hydrochloride rated?
pharmaranks gives Dolophine Hydrochloride a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
How much does Dolophine Hydrochloride cost?
Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.18 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Imodium A-D — about $0.05 on the same basis.
Is there a coupon or discount for Dolophine Hydrochloride?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dolophine Hydrochloride. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Dolophine Hydrochloride?
Dolophine Hydrochloride is marketed by Hikma. You can see Hikma's full profile, rating, and other products on pharmaranks.
Is Dolophine Hydrochloride a brand-name or generic drug?
Dolophine Hydrochloride is a brand-name product with the active ingredient Methadone Hydrochloride. Lower-cost generic equivalents containing Methadone Hydrochloride are available — ask your pharmacist.
Is Dolophine Hydrochloride available over the counter?
No. Dolophine Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Dolophine Hydrochloride come in?
Dolophine Hydrochloride is currently marketed as tablet and syrup, per the FDA's National Drug Code Directory.
What class of drug is Dolophine Hydrochloride?
Dolophine Hydrochloride is classified as opioid agonist, per the FDA's Established Pharmacologic Class.
Is Dolophine Hydrochloride FDA-registered?
Dolophine Hydrochloride is on record with the U.S. FDA under application number NDA006134. You can verify this on its official FDA label.
Has Dolophine Hydrochloride been recalled by the FDA?
Dolophine Hydrochloride has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Dolophine Hydrochloride safe?
There's no single safe-or-not verdict. pharmaranks gives Dolophine Hydrochloride a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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dolophine hydrochloride

72/100