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Hydrocodone

Hydrocodone is an opioid pain medicine, given as extended-release capsules or tablets, for severe, persistent pain that needs round-the-clock treatment when other options aren't enough.

Brand names HysinglaZohydro ERZohydroHysingla ER
Drug class Opioid Agonists
Rx Schedule CII Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Hydrocodone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Hydrocodone extended-release (Hysingla ER, Zohydro ER) is a long-acting opioid, acting on pain receptors in the brain and spinal cord, reserved for severe, round-the-clock pain when other treatments, including short-acting opioids, fall short; hydrocodone itself has been on the U.S. market since about 1987 and is available generically. Side effects mirror other opioids, mainly constipation, which rarely fades, plus nausea and sleepiness, which often ease as you adjust. Its boxed warning covers addiction, misuse and overdose, and life-threatening slowed breathing, most likely early on or after a dose increase and far riskier with alcohol or sedatives. Swallow it whole and lock it up, since one dose can kill a child.

Clinical pearls

  • Keep naloxone, the overdose-reversal medicine sold as a nasal spray, at home and make sure family knows where it is.
  • Erythromycin, ketoconazole and ritonavir can push hydrocodone to dangerous levels, and so can stopping rifampin or carbamazepine.
  • Gabapentin and pregabalin, often prescribed for nerve pain, add to the breathing risk just like sleep aids and benzodiazepines.
  • If you have taken it daily for a while, never stop suddenly; your prescriber can taper the dose to prevent withdrawal.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Hydrocodone can cause addiction, life-threatening slowed breathing, and fatal overdose, especially in children who take it by accident.

  • Addiction and misuse: can lead to overdose and death. Your prescriber should check your risk and follow up regularly.
  • Slowed breathing: greatest risk when starting or raising the dose. Swallow the product whole, because crushing, chewing or dissolving it can release a fatal dose.
  • Accidental ingestion: even one dose can be fatal for a child.
  • Sedatives and alcohol: combining them can cause profound sleepiness, breathing trouble, coma and death. Avoid alcohol and alcohol-containing products.
  • Pregnancy: long-term use can cause life-threatening withdrawal in a newborn.
  • Other medicines: CYP3A4 inhibitors, or stopping CYP3A4 inducers, can raise hydrocodone levels and cause fatal breathing problems.

Opioid pain medicines are also covered by an FDA safety program (REMS). Read the Medication Guide each time you fill your prescription.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asExtended-release tablet, Extended-release capsule
Earliest FDA record1943
Companies listing it with the FDA2
FDA label last updatedMay 29, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Hydrocodone, written from its FDA label.

What Hydrocodone is used for

▾

Hydrocodone extended-release products treat severe, persistent pain that needs an opioid pain reliever.

  • Hydrocodone bitartrate extended-release capsules (oral): severe and persistent pain needing an extended treatment period with a daily opioid when alternatives are inadequate.
  • Hydrocodone bitartrate extended-release tablets (oral): severe and persistent pain that needs an opioid and can't be adequately treated with other options, including immediate-release opioids.
  • Hysingla ER (oral tablet): the same use as the tablets above.
  • None of these are for as-needed pain relief.

How Hydrocodone works

▾

Hydrocodone is a full opioid agonist. It binds mainly to mu-opioid receptors in the brain and spinal cord, which are involved in pain signaling. This reduces the feeling of pain.

The exact way it relieves pain isn't fully known. Its pain relief has no ceiling, so doses are raised slowly and may be limited by side effects like slowed breathing and drowsiness.

Hydrocodone dosage

▾

These medicines are taken by mouth and swallowed whole.

  • Hydrocodone bitartrate extended-release capsules: about every 12 hours.
  • Hydrocodone bitartrate extended-release tablets and Hysingla ER: once daily, one tablet at a time with enough water to swallow right away. The tablets can be taken without regard to meals.
  • Never cut, crush, chew or dissolve them.
  • Do not stop suddenly if you are physically dependent. Your prescriber will guide any reduction.

Your prescriber sets your dose and adjusts it slowly. Follow the label and your prescriber's directions.

Dosing details from the FDA-approved label

From the Hydrocodone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Opioid-naïve and opioid non-tolerant patients (extended-release capsules)
    • Initiate with 10 mg capsules orally every 12 hours
    • Dose titration may occur every 3 to 7 days, using increments of 10 mg every 12 hours (i.e., 20 mg per day)
    • Maximum: A single dose greater than 40 mg, or a total daily dose greater than 80 mg, is only for use in patients in whom tolerance to an opioid of comparable potency has been established
  • Patients with severe hepatic impairment (extended-release capsules)
    • Initiate dosing with 10 mg every 12 hours and titrate carefully, while monitoring for respiratory depression, sedation, and hypotension
    • No adjustment in starting dose is required in patients with mild or moderate hepatic impairment
  • Patients who are not opioid tolerant (extended-release tablets)
    • Initiate with 20 mg tablets orally every 24 hours
    • Dose titration may occur every 3 to 5 days
    • Maximum: Daily doses greater than or equal to 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Hydrocodone bitartrate extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) Daily doses of hydrocodone bitartrate extended-release tablets greater than or equal to 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. ( 2.1 ) Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. ( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ( 2.1 ) Reserve titration to higher doses of hydrocodone bitartrate extended-release tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5.1 ) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with hydrocodone bitartrate extended-release tablets. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) Hydrocodone bitartrate extended-release tablets are administered orally once daily (every 24 hours). ( 2.1 ) Instruct patients to swallow hydrocodone bitartrate extended-release tablets intact, and not to crush, chew, or dissolve the tablets (risk of potentially fatal overdose). ( 2.1 , 5.1 ) Instruct patients to take tablets one at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. ( 2.1 , 5.13 ) For patients who are not opioid tolerant, initiate with 20 mg tablets orally every 24 hours.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Hydrocodone side effects

▾

The most common side effects seen in studies were:

Common side effects

  • Nausea
  • Constipation
  • Vomiting
  • Dizziness
  • Headache
  • Sleepiness (somnolence)
  • Fatigue
  • Itching

When to get medical help

  • Call 911 right away for slow or shallow breathing, extreme sleepiness, trouble waking, or a known or suspected overdose.
  • Get help if a child or anyone else takes a dose by accident. Even one dose can be fatal.
  • Tell your doctor if you notice signs of addiction, abuse or misuse, or if your pain gets worse or more sensitive while on treatment.
  • Seek help for severe dizziness, fainting or very low blood pressure.
  • Call your doctor if you have signs of serotonin syndrome while taking other serotonin-affecting medicines.
  • Tell your doctor about trouble swallowing, choking or signs of a bowel blockage.
  • Do not stop suddenly if you are physically dependent. Talk to your prescriber first.

Get help right away for slowed breathing, severe drowsiness, fainting, seizures, signs of addiction, or symptoms of serotonin syndrome or adrenal insufficiency.

Hydrocodone warnings and precautions

▾
  • Addiction, abuse and misuse can occur even at recommended doses, and overdose risk rises with higher doses.
  • Slowed breathing can be fatal, especially when starting or increasing the dose. Older, frail or lung-disease patients are at higher risk.
  • Accidental ingestion, especially by children, can be fatal.
  • Opioids can cause sleep-related breathing problems, severe low blood pressure, adrenal insufficiency, and increased pain sensitivity (hyperalgesia).
  • QTc prolongation (a heart rhythm change) can occur. Avoid use with congenital long QT syndrome.
  • Tablets can swell into a gel, so people with trouble swallowing or GI narrowing may need an alternative.
  • Long-term use may reduce fertility and affect hormones.

Hydrocodone interactions

▾

Several medicines can change how hydrocodone works or add to its risks.

  • Alcohol, benzodiazepines and other sedating drugs: dangerous sleepiness and slowed breathing.
  • CYP3A4 inhibitors (erythromycin, ketoconazole, ritonavir): raise hydrocodone levels.
  • CYP3A4 inducers (rifampin, carbamazepine, phenytoin): lower effect, and stopping them can raise levels.
  • MAOIs: not recommended within 14 days.
  • Serotonergic drugs (SSRIs, SNRIs, triptans, tramadol): risk of serotonin syndrome.
  • Buprenorphine, butorphanol, nalbuphine, pentazocine: may cause withdrawal or reduce pain relief.
  • Muscle relaxants, anticholinergics, diuretics and strong laxatives: can change breathing, bowel, urine or drug effects.

Interactions listed in the FDA-approved label

From the Hydrocodone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Inhibitors of CYP3A4 (e.g., erythromycin, ketoconazole, ritonavir): Can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects; after stopping the inhibitor, hydrocodone concentration will decrease, resulting in decreased opioid efficacy or a withdrawal syndrome in physically dependent patients. If concomitant use is necessary, consider dosage reduction until stable drug effects are achieved and evaluate patients at frequent intervals for respiratory depression and sedation. If the inhibitor is discontinued, consider increasing the dosage until stable drug effects are achieved and assess for signs of opioid withdrawal.
  • CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin): Can decrease the plasma concentration of hydrocodone, resulting in decreased efficacy or withdrawal syndrome in physically dependent patients; after stopping the inducer, hydrocodone concentration will increase, which could increase or prolong therapeutic effects and adverse reactions and may cause serious respiratory depression. If concomitant use is necessary, consider increasing the dosage until stable drug effects are achieved and evaluate for signs of opioid withdrawal. If the inducer is discontinued, consider dosage reduction and evaluate patients at frequent intervals for respiratory depression and sedation.
  • Benzodiazepines and other CNS depressants (including alcohol): Due to additive pharmacologic effect, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Reserve concomitant prescribing for patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; inform patients and caregivers and educate them on signs and symptoms of respiratory depression; if concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol, linezolid): Concomitant use of opioids with drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment; discontinue hydrocodone if serotonin syndrome is suspected.
  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, linezolid): MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). Use is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
  • Mixed agonist/antagonist and partial agonist opioid analgesics (butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of hydrocodone and/or precipitate withdrawal symptoms. Avoid concomitant use.
  • Muscle relaxants (e.g., cyclobenzaprine, metaxalone): Hydrocodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Decrease the dosage of hydrocodone and/or the muscle relaxant as necessary; consider recommending or prescribing an opioid overdose reversal agent.
  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Evaluate patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
  • Anticholinergic drugs: May increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Evaluate patients for signs of urinary retention or reduced gastric motility.
  • Strong laxatives (e.g., lactulose): Strong laxatives that rapidly increase gastrointestinal motility may decrease hydrocodone absorption and result in decreased hydrocodone plasma levels. Regularly evaluate for the development of adverse events as well as changing analgesic requirements.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with hydrocodone bitartrate extended-release tablets. Table 3: Clinically Significant Drug Interactions with Hydrocodone Bitartrate Extended-Release Tablets Inhibitors of CYP3A4 Clinical Impact: The concomitant use of hydrocodone bitartrate extended-release tablets and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of hydrocodone bitartrate extended-release tablets and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of hydrocodone bitartrate extended-release tablets is achieved [see Warnings and Precautions ( 5.6 )] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [see Clinical Pharmacology ( 12.3 )] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to hydrocodone. Intervention: If concomitant use is necessary, consider dosage reduction of hydrocodone bitartrate extended-release tablets until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the hydrocodone bitartrate extended-release tablets dosage until stable drug effects are achieved. Assess for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿212 supplements and herbs with documented Hydrocodone interactions, ranked by severity Check Hydrocodone against a supplement or herb →

Before taking Hydrocodone

▾
  • Do not use with significant breathing problems, acute or severe asthma without monitoring, bowel blockage or paralytic ileus, or allergy to hydrocodone.
  • Tell your prescriber about substance use history or mental illness.
  • Pregnancy: long-term use can cause newborn withdrawal and may cause fetal harm. Not recommended during or right before labor.
  • Breastfeeding is not recommended.
  • Children: safety and effectiveness not established.
  • Older adults: use caution and slow dose increases.
  • Severe liver disease or moderate to severe kidney disease may call for lower starting doses.

Hydrocodone overdose

▾

Overdose can cause slowed breathing, extreme sleepiness progressing to coma, cold and clammy skin, small pupils, low heart rate and low blood pressure. Call 911 right away. Treatment includes support of breathing and an opioid reversal medicine such as naloxone, with prolonged monitoring because extended-release products keep releasing medicine for 24 to 48 hours or longer.

What Hydrocodone does in the body

▾

Hydrocodone slows breathing by acting on the brainstem's breathing centers. It narrows pupils and slows movement through the gut, causing constipation. It widens blood vessels, which can drop blood pressure on standing. Long-term use can lower certain hormones. At high doses, it can lengthen the QTc interval.

How your body processes Hydrocodone

▾

The extended-release tablet releases hydrocodone gradually, with peak levels around 14 to 16 hours after a dose. Half-life is about 7 to 9 hours. The tablets can be taken with or without food. Hydrocodone is mainly broken down by the liver enzyme CYP3A4, which is why interacting drugs matter.

How to store Hydrocodone

▾

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) . Dispense in tight, light-resistant container, as defined by the USP. Store HYSINGLA ER securely and dispose of properly.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

212

Supplements & herbs that interact with Hydrocodone

212 supplements and herbal products have documented interactions with Hydrocodone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 164
  • Minor · 39
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major GRAPEFRUIT Major KAVA Major L-TRYPTOPHAN Major ST. JOHN'S WORT Major +204 more
Every supplement checked against Hydrocodone — ranked by severity The full interaction hub: 9 major · 164 moderate · 39 minor · every one linked to its full report. Check Hydrocodone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Hydrocodone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Hydrocodone — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

▾
Hydrocodone extended-release is for severe, persistent pain that needs an around-the-clock opioid when other treatments haven't worked or aren't enough. It isn't meant for as-needed pain relief.

How should I take it?

▾
Swallow it whole, by mouth. Never crush, chew, cut or dissolve it, since that can release a dangerous dose at once. The capsules are taken about every 12 hours and the tablets once a day, so follow your label closely.

Can I drink alcohol while taking it?

▾
No. Alcohol can raise hydrocodone levels and cause a potentially fatal overdose. Avoid alcohol-containing products too, and check with me before combining it with sleep aids, anxiety medicines or muscle relaxants.

What side effects should I expect?

▾
Nausea, constipation, vomiting, dizziness, headache, sleepiness and fatigue are the most common. Call for help right away if breathing slows, you can't stay awake, or you faint.

How should I store it, and what is naloxone?

▾
Keep it locked up and out of reach, because even one dose can be fatal to a child. Naloxone is a reversal medicine for opioid overdose, so ask your prescriber about having it at home.

Is it safe in pregnancy or while breastfeeding?

▾
Long-term use during pregnancy can cause withdrawal in the newborn, which can be life-threatening. Breastfeeding isn't recommended while you take it. Talk with your doctor right away if you are pregnant or planning to be.

Is Hydrocodone available over the counter?

▾
No. Hydrocodone is a prescription medicine: every Hydrocodone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Hydrocodone a controlled substance?

▾
Yes — Hydrocodone is a federally controlled substance (Schedule II) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Hydrocodone first available?

▾
The earliest FDA record we hold for Hydrocodone is from 1943: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Hydrocodone was first used.

Who makes Hydrocodone?

▾
2 companies currently list Hydrocodone products in the FDA's NDC Directory, including Alvogen Inc., Knoa Pharma LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Hydrocodone on HelloPharmacist

📊Hydrocodone supplement interactions212 checked — ranked by severity 🌿Drug & Supplement CheckerHydrocodone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Hydrocodone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Hydrocodone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Hydrocodone forms and strengths (how it comes)

Hydrocodone is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Extended-release tablet

By mouth
Brands Hysingla ER
How this form is used
What it may be used for
  • Hydrocodone Bitartrate extended-release tablets are for severe, persistent pain that needs an opioid and can't be adequately treated with other options, including immediate-release opioids.
  • Hysingla ER is for the same type of severe, persistent pain when other options, including immediate-release opioids, are inadequate.
  • Neither Hydrocodone Bitartrate extended-release tablets nor Hysingla ER are for as-needed pain relief.
Important instructions
  • Hydrocodone Bitartrate extended-release tablets and Hysingla ER are taken by mouth once daily (every 24 hours).
  • Swallow Hysingla ER intact. Do not crush, chew or dissolve it.
  • Take Hydrocodone Bitartrate extended-release tablets one at a time with enough water to swallow each immediately.
Available strengths 7 strengths
20 mg 30 mg 40 mg 60 mg 80 mg 100 mg
Show 1 more strength Show fewer strengths
120 mg
39 FDA-listed product records ⓘ

Extended-release capsule

By mouth
How this form is used
What it may be used for
  • Hydrocodone Bitartrate extended-release capsules are for severe, persistent pain that needs an extended period of daily opioid treatment when other options are inadequate.
  • Hydrocodone Bitartrate extended-release capsules are not for as-needed pain relief.
Important instructions
  • Hydrocodone Bitartrate extended-release capsules are taken by mouth about every 12 hours.
  • Swallow Hydrocodone Bitartrate extended-release capsules intact. Do not cut, break, chew, crush or dissolve them.
  • Ask your prescriber about having naloxone available with Hydrocodone Bitartrate extended-release capsules.
Available strengths 6 strengths
10 mg 15 mg 20 mg 30 mg 40 mg 50 mg
18 FDA-listed product records ⓘ

Hydrocodone on the U.S. market: products, makers and brands

How Hydrocodone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2 companies list 19 Hydrocodone product records with the FDA, mostly as extended-release tablet, extended-release capsule; the earliest marketing or approval year on record is 1943. Brand names on the directory include Hysingla, Zohydro ER, Zohydro and 1 more; the rest are generics.

2
Dose forms ⓘ
2
Labelers (makers, repackagers, distributors)
2
Brand names
19
FDA-listed product records ⓘ
1943
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Alvogen Inc.68%
Knoa Pharma LLC32%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Hydrocodone is used (Medicaid data)

A general measure of how commonly Hydrocodone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Hydrocodone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,748
Medicaid prescriptions filled (Q1–Q4 2025)
$932,136 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Hydrocodone prescribed? Of the 1,601 medications we measure, Hydrocodone ranks #1,204 by Medicaid prescriptions — more than 25% of them.

Where Hydrocodone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,204 of 1,601
#1,199 Ganciclovir Ophthalmic 1,891 Rx #1,200 Naftifine Topical 1,859 Rx #1,201 Mefenamic Acid 1,776 Rx #1,202 Rotigotine Transdermal... 1,775 Rx #1,203 Ceftazidime and Avibac... 1,753 Rx #1,204 Hydrocodone 1,748 Rx #1,205 Palivizumab Injection 1,742 Rx #1,206 Obinutuzumab Injection 1,741 Rx #1,207 Bosutinib 1,739 Rx #1,208 Trifluridine and Tipir... 1,725 Rx #1,209 Pyrazinamide 1,725 Rx

Utilization by Hydrocodone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 24 HR / 20 mg extended release oral tablet is the most-dispensed Hydrocodone product — about 49% of these Medicaid prescriptions.

Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet Most dispensed

859 Medicaid prescriptions (Q1–Q4 2025) 49% of Hydrocodone prescriptions shown $325,461 gross reimbursement (before rebates) ≈ $379 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1595730

Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral Tablet

437 Medicaid prescriptions (Q1–Q4 2025) 25% of Hydrocodone prescriptions shown $255,778 gross reimbursement (before rebates) ≈ $585 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1595740

Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG Extended Release Oral Tablet

365 Medicaid prescriptions (Q1–Q4 2025) 21% of Hydrocodone prescriptions shown $266,933 gross reimbursement (before rebates) ≈ $731 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1595746

Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet

87 Medicaid prescriptions (Q1–Q4 2025) 5% of Hydrocodone prescriptions shown $83,964 gross reimbursement (before rebates) ≈ $965 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1595752

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Hydrocodone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 8 listed Hydrocodone NDCs with Medicaid activity.

Compare Hydrocodone products

A representative set of FDA-listed product records for Hydrocodone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 19 of 19 products — FDA National Drug Code Directory. See every product, package size and price: browse all 19 Hydrocodone NDCs →

Hydrocodone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Hydrocodone recalls since July 2021.

✅No Hydrocodone recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Hydrocodone RxCUI 5489 3 dose forms · 14 strengths
  2. Dose form (SCDF) Extended Release Oral Tablet RxCUI 1595729 In current FDA listings
    Clinical drug / strength (SCD) Abuse-Deterrent 24 HR hydrocodone bitartrate 100 MG RxCUI 1595764 Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG RxCUI 1595770 Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG RxCUI 1595730 Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG RxCUI 1595740 Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG RxCUI 1595746 Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG RxCUI 1595752 Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG RxCUI 1595758
  3. Dose form (SCDF) Oral Tablet RxCUI 372410 No current FDA listing
    Clinical drug / strength (SCD) bitartrate 7.5 MG RxCUI 860599

Look up RxCUI 5489 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Hydrocodone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Extended Release · Oral 20 mg $8.02 per tablet NDC details & price history
Capsule, Extended Release · Oral 30 mg $7.21 per capsule NDC details & price history
Capsule, Extended Release · Oral 20 mg $6.87 per capsule NDC details & price history
Capsule, Extended Release · Oral 15 mg $7.95 per capsule NDC details & price history
Capsule, Extended Release · Oral 10 mg $7.38 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Hydrocodone brand names

Hydrocodone is sold under 4 brand names in the FDA directory — Hysingla, Zohydro ER, Zohydro, Hysingla ER. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Hysingla Zohydro ER Zohydro Hysingla ER

Who makes Hydrocodone: manufacturers and labelers

2 companies list Hydrocodone products with the FDA. By number of product records, the largest are Alvogen Inc., Knoa Pharma LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Alvogen Inc. 13 Knoa Pharma LLC 6

Hydrocodone drug class (RxNorm)

Hydrocodone belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Opium alkaloids and derivatives
How it works Opioid Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Hydrocodone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 29, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Hydrocodone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Hydrocodone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
Finished products in the current FDA directory
19
Companies listing them (makers, repackagers, distributors)
2
FDA labeler codes behind them ⓘ
2
Linked representative label ⓘ
Purdue Pharma LP
Linked label effective
May 29, 2026
Composite sections available
27
Linked SPL Set ID
b7d23ac2-e776-9f62-3290-c64c2d6eb353
Linked SPL Document ID
556f1138-72ae-4693-ba62-75df59060197
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Purdue Pharma LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →