exalgo
Pharmaranks rates Exalgo 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Exalgo (Hydromorphone Hydrochloride) is an opioid agonist used to treat Cough, Postoperative Pain.
Hydromorphone Hydrochloride · by Specgx LLC
Available as a generic: Hydromorphone Hydrochloride
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 →
Key facts
- Active ingredient
- Hydromorphone Hydrochloride
- Drug class
- Opioid Agonist
- Form
- Tablet, extended release
- Strength
- Hydromorphone Hydrochloride 12MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Hydromorphone Hydrochloride 16MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Hydromorphone Hydrochloride 32MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Hydromorphone Hydrochloride 8MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- cough, postoperative pain
- Manufacturer
- Specgx LLC
- Half-life
- about 2.3 hours (terminal elimination half-life after an intravenous dose); after an oral dose the label reports a mean T½ of about 2.6 hours for the 8 mg tablet and 2.8 hours for the oral liquid (how long it stays in your system)
- What the pharmacy pays
- ~$0.57 per ml — not your price
- FDA application
- NDA021217
- Availability
- Discontinued (per FDA)
How long does Hydromorphone Hydrochloride stay in your body?
The elimination half-life of hydromorphone hydrochloride is about 2.3 hours (terminal elimination half-life after an intravenous dose); after an oral dose the label reports a mean T½ of about 2.6 hours for the 8 mg tablet and 2.8 hours for the oral liquid — 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. These are the terminal (elimination) values the label gives, not a distribution phase. No longer-lasting active metabolite: the label states plainly that "the analgesic activity of hydromorphone hydrochloride is due to the parent drug, hydromorphone." Over 95% of a dose is converted to hydromorphone-3-glucuronide (plus minor 6-hydroxy reduction metabolites), which the label does not describe as analgesically active. Hydromorphone is not a prodrug. Kidney impairment: the drug is cleared more slowly — in the label's renal study, severe impairment (CLcr under 30 mL/min) gave a terminal half-life of about 40 hours versus about 15 hours in people with normal kidneys, and exposure rose 2-fold in moderate and 3-fold in severe impairment. Note the label's own inconsistency: that study's "normal kidney" comparator (about 15 hours) is much longer than the roughly 2.3-2.8 hours reported elsewhere in the same label, likely because of longer blood sampling; the label prints both without reconciling them, so treat the ~40 vs ~15 hour figures as a relative comparison within that one study rather than as the everyday number. Liver impairment: moderate impairment (Child-Pugh B) raised exposure about 4-fold; the label does not report a half-life for it, and severe impairment was never studied. Older adults: the label says age has no effect on hydromorphone pharmacokinetics. This is elimination from blood, not a drug-test detection window (metabolites stay detectable much longer), and it is not dosing guidance.
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: HYDROMORPHONE HYDROCHLORIDE tablet - FDA label, Section 12.3 Pharmacokinetics (DailyMed).
Drug class
How this class works, per Mu Receptors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Exalgo ranks — best-rated opioid agonist for:
Dosage forms
Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Exalgo treat?
- Exalgo (Hydromorphone Hydrochloride) may be used to treat cough, postoperative 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 Exalgo work?
- Exalgo 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 Exalgo rated?
- pharmaranks gives Exalgo a composite score of 3.5 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 Exalgo 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 $0.57 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 Exalgo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Exalgo. 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 Exalgo?
- Exalgo is marketed by Specgx LLC. You can see Specgx LLC's full profile, rating, and other products on pharmaranks.
- Is Exalgo a brand-name or generic drug?
- Exalgo is a brand-name product with the active ingredient Hydromorphone Hydrochloride. Lower-cost generic equivalents containing Hydromorphone Hydrochloride are available — ask your pharmacist.
- Is Exalgo available over the counter?
- No. Exalgo 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 Exalgo come in?
- Exalgo is currently marketed as tablet, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Exalgo?
- Exalgo is classified as opioid agonist, per the FDA's Established Pharmacologic Class.
- Is Exalgo FDA-registered?
- Exalgo is on record with the U.S. FDA under application number NDA021217. You can verify this on its official FDA label.
- Has Exalgo been recalled by the FDA?
- Exalgo 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 Exalgo safe?
- There's no single safe-or-not verdict. pharmaranks gives Exalgo a recall-safety score of 70/100, 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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exalgo
70/100