Prescription medicine
Homatropine methylbromide and hydrocodone First approved as Hycodan
Homatropine methylbromide and hydrocodone (Hycodan) is a prescription medicine with an FDA approval on record since 1943. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $0.922 per hydrocodone-homatropine 5-1.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the homatropine methylbromide and hydrocodone FDA label on DailyMed (effective May 7, 2026, Genus Lifesciences Inc.); the NDA 5213 record on Drugs@FDA; every homatropine methylbromide and hydrocodone label on DailyMed.
Highlights of the record
FDA label of May 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME.
Addiction, Abuse, and Misuse Hydrocodone bitartrate and homatropine methylbromide exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient's risk prior to prescribing hydrocodone bitartrate and homatropine methylbromide, prescribe hydrocodone bitartrate and homatropine methylbromide for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and homatropine methylbromide. […]
Used for
From the label: indications and usageHydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older.
Forms and strengths
- 5 mg/5ml / 1.5 mg/5ml
- 5 mg / 1.5 mg
Tablet; solution; liquid; syrup.
On the market
- Earliest approval on file
- March 23, 1943 Hycodan, Genus; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first March 3, 1983; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.922 per tablet Hydrocodone-homatropine 5-1.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2018 0 Class I among all firms' recalls; latest April 27, 2021
- FAERS reports
- 32 through July 30, 2026
What is homatropine methylbromide and hydrocodone used for?
From the label: indications and usageHydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]. Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4) ]. […]
Conditions named in the indications of homatropine methylbromide and hydrocodone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Hydrocodone Bitartrate and Homatropine Methylbromide), Genus Lifesciences Inc., effective May 7, 2026 (SPL set 320ff639-9854-407b-9bbd-a035c4f173e1), via openFDA; the full label on DailyMed
What does the patient leaflet for homatropine methylbromide and hydrocodone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Hydrocodone Bitartrate and Homatropine Methylbromide?Hydrocodone bitartrate and homatropine methylbromide is not for children under 18 years of age. Hydrocodone bitartrate and homatropine methylbromide can cause serious side effects, including: Addiction, abuse and misuse. Taking hydrocodone bitartrate and homatropine methylbromide or other medicines that contain an opioid can cause addiction, abuse and misuse, which can lead to overdose and death. This can happen even if you take hydrocodone bitartrate and homatropine methylbromide exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems. Do not share your hydrocodone bitartrate and homatropine methylbromide with other people. Keep hydrocodone bitartrate and homatropine methylbromide in a safe place away from children. Life-threatening breathing problems (respiratory depression). Hydrocodone bitartrate and homatropine methylbromide can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking hydrocodone bitartrate and homatropine methylbromide, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly, or have certain other health problems. Children are at higher risk for respiratory depression. Breathing problems can happen even if you take hydrocodone bitartrate and homatropine methylbromide exactly as prescribed by your healthcare provider. […]
From the patient leaflet: What should I avoid while taking hydrocodone bitartrate and homatropine methylbromide?Avoid driving a car or operating machinery during treatment with hydrocodone bitartrate and homatropine methylbromide. Hydrocodone bitartrate and homatropine methylbromide can cause you to be drowsy, slow your thinking and motor skills, and affect your vision. Do not drink alcohol during treatment with hydrocodone bitartrate and homatropine methylbromide. Drinking alcohol can increase your chances of having serious side effects. Avoid the use of hydrocodone bitartrate and homatropine methylbromide if you: are pregnant. Use of hydrocodone bitartrate and homatropine methylbromide during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Tell your healthcare provider right away if you are pregnant or think you may be pregnant. are breastfeeding. […]
From the patient leaflet: How should I store hydrocodone bitartrate and homatropine methylbromide?Store hydrocodone bitartrate and homatropine methylbromide at room temperature between 68°F to 77°F (20°C to 25°C). Store hydrocodone bitartrate and homatropine methylbromide tablets in a tightly closed container, in a dry, cool place away from heat or direct sunlight. Keep hydrocodone bitartrate and homatropine methylbromide and all medicines out of the reach of children.
Source: FDA drug label (Hydrocodone Bitartrate and Homatropine Methylbromide), Genus Lifesciences Inc., effective May 7, 2026 (SPL set 320ff639-9854-407b-9bbd-a035c4f173e1), via openFDA; the full label on DailyMed
Is there a generic for homatropine methylbromide and hydrocodone (Hycodan)?
The FDA approved the first generic homatropine methylbromide and hydrocodone on March 3, 1983. 14 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists homatropine methylbromide and hydrocodone from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1943 earliest approval on file
- 1983 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for homatropine methylbromide and hydrocodone (Hycodan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.922 per Hydrocodone-homatropine 5-1.5 mg tablet, down 5% from $0.967 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Hydrocodone-homatropine 5-1.5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydrocodone-homatropine 5-1.5 mg tablet | Generic | $0.922 per tablet | $27.65 | -5% |
| Hydrocodone-homatropine solution | Generic | $0.103 per mL | n/a | +8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has homatropine methylbromide and hydrocodone been recalled?
The FDA's Enforcement Report lists 5 recalls naming homatropine methylbromide and hydrocodone since 2018: 0 Class I (the most serious), 3 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 27, 2021 | Class III | KVK-Tech, Inc. | Failed Impurities/Degradation Specifications |
| November 1, 2019 | Class II | KVK-Tech, Inc. | Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection |
| May 21, 2019 | Class II | Torrent Pharma Inc | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). |
| March 5, 2018 | Class III | Novel Laboratories, Inc. | Failed Impurities/Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the homatropine methylbromide and hydrocodone label say about other medicines?
The homatropine methylbromide and hydrocodone label names 12 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | The concomitant use of hydrocodone bitartrate and homatropine methylbromide and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who … |
| Cyclobenzaprine | drug interactions | Hydrocodone may enhance the neuromuscular blocking action of skeletal muscle relaxants (e.g., cyclobenzaprine, metaxalone) and produce an increased degree of respiratory depression. |
| Erythromycin | drug interactions | The concomitant use of hydrocodone bitartrate and homatropine methylbromide and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or … |
| Gabapentin | drug interactions | Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of … |
| Ketoconazole | drug interactions | The concomitant use of hydrocodone bitartrate and homatropine methylbromide and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or … |
| Metaxalone | drug interactions | Hydrocodone may enhance the neuromuscular blocking action of skeletal muscle relaxants (e.g., cyclobenzaprine, metaxalone) and produce an increased degree of respiratory depression. |
| Nalmefene | warnings and precautions | Management of respiratory depression includes discontinuation of hydrocodone bitartrate and homatropine methylbromide, close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone or nalmefene), depending on the patient's clinical status [see Overdosage (10) ]. |
| Naloxone | warnings and precautions | Management of respiratory depression includes discontinuation of hydrocodone bitartrate and homatropine methylbromide, close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone or nalmefene), depending on the patient's clinical status [see Overdosage (10) ]. |
| Phenytoin | drug interactions | The concomitant use of hydrocodone bitartrate and homatropine methylbromide and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who … |
| Pregabalin | drug interactions | Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of … |
| Rifampin | drug interactions | The concomitant use of hydrocodone bitartrate and homatropine methylbromide and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who … |
| Ritonavir | drug interactions | The concomitant use of hydrocodone bitartrate and homatropine methylbromide and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or … |
Check homatropine methylbromide and hydrocodone against other medicines
Source: FDA drug label (Hydrocodone Bitartrate and Homatropine Methylbromide), Genus Lifesciences Inc., effective May 7, 2026 (SPL set 320ff639-9854-407b-9bbd-a035c4f173e1), via openFDA; the full label on DailyMed
What do FAERS reports show for homatropine methylbromide and hydrocodone?
The FDA Adverse Event Reporting System holds 32 reports that list homatropine methylbromide and hydrocodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 2 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as homatropine methylbromide and hydrocodone?
17 other medicines are given the same way (oral) and in the same FDA class as homatropine methylbromide and hydrocodone or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Codeine and promethazine | Cough and cold | 5 labelers | $0.0697 per mL Promethazine-codeine solution | No current entry |
| Chlorpheniramine and codeine | Cough and cold | none listed | n/a | No current entry |
| Codeine and phenylephrine and promethazine | Cough and cold | 1 labeler | n/a | No current entry |
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Dextromethorphan and guaifenesin | Cough and cold | 61 labelers | $0.0207 per mL 200-20 mg/20 mL | No current entry |
| Guaifenesin | Cough and cold | 102 labelers | $0.284 per tablet 600 mg tablet | No current entry |
| Benzonatate | Cough and cold | 45 labelers | $0.0656 per capsule 100 mg capsule | No current entry |
| Dextromethorphan | Cough and cold | 28 labelers | $0.122 per unit 15 mg softgel | No current entry |
Every medicine labeled for the same conditions as homatropine methylbromide and hydrocodone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to homatropine methylbromide and hydrocodone
- 17 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Homatropine methylbromide and hydrocodone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other