Hydrocodone Bitartrate and Acetaminophen 10 mg; 325 mg Tablet, 500-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.152 | $76.10 / 500 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2309 | $115.45 / 500 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2311 | $115.55 / 500 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen 325 mg/1; 10 mg 42806-0113-01 | Epic | 100 tablets | $0.135 | AA | FDA listed | save 12% |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 00406-0125-01 | SpecGx | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 10702-0191-01 | KVK-Tech, | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 13107-0021-01 | Aurolife | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 27808-0037-01 | Cranbury | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 31722-0997-01 | Camber | 100 tablets | $0.152 | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 42858-0203-01 | Rhodes | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 50268-0402-15 | AvPAK | 50 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 53746-0110-01 | Amneal | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 60687-0418-01 | American | 100 tablets | $0.152 | AA | Availability likely | — |
| hydrocodone bitartrate and acetaminophen 10 mg/1; 325 mg 64380-0442-01 | Strides | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 64850-0633-01 | Elite | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mgthis 71930-0021-52 | Eywa | 500 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 43386-0358-01 | Lupin | 100 tablets | $0.153 | — | Availability likely | +1% |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 00245-0412-01 | Upsher-Smith | 100 tablets | — | — | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 55700-0991-30 | Quality | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 60429-0592-01 | Golden | 100 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 60760-0871-30 | ST. | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 325 mg/1; 10 mg 60760-0872-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63187-0120-20 | Proficient | 20 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63187-0778-12 | Proficient | 12 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 325 mg/1; 10 mg 63304-0497-01 | Sun | 100 tablets | — | — | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-1938-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2298-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2299-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2300-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2470-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2471-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-8886-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 66267-0319-30 | NuCare | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 68071-4941-06 | NuCare | 6 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 70010-0674-01 | Granules | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71205-0660-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1271-00 | Bryant | 120 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1339-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1418-00 | Bryant | 120 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1444-01 | Bryant | 21 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-2105-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-2118-00 | Bryant | 120 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-2740-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-9602-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-9735-00 | Bryant | 120 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72162-1281-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72162-1991-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72162-2271-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 325 mg/1; 10 mg 72189-0348-30 | DirectRx | 30 tablets | — | AA | FDA listed | — |
| Norco 10 mg/1; 325 mg 72189-0399-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone/APAP 10 mg/1; 325 mg 72189-0650-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72865-0112-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72865-0204-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 76420-0215-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 76420-0877-00 | Asclemed | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 82804-0003-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 87063-0051-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 71930-0021-12 | 100 TABLET in 1 BOTTLE (71930-021-12) | $0.1522 / ea | $15.22 | 2018-07-13 | Active |
| 71930-0021-13 | 1000 TABLET in 1 BOTTLE (71930-021-13) | $0.1522 / ea | $152.21 | 2022-10-06 | Active |
| 71930-0021-52 You're viewing this | 500 TABLET in 1 BOTTLE (71930-021-52) | $0.1522 / ea | $76.11 | 2018-07-13 | Active |
You're viewing one of 3 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.1522 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 79% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 71930-0021-52?
What is the difference between NDC 71930-0021-52 and NDC 71930-0021-12?
What NDC number is used to bill for this package of Hydrocodone Bitartrate and Acetaminophen 10 mg; 325 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDRCODONE BITARTRATE AND ACETAMINOPHEN TABLETS Addiction, Abuse, and Misuse Because the use of Hydrocodone Bitartrate and Acetaminophen Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Acetaminophen Tablets especially during initiation or following a dosage increase.
To reduce the risk of respiratory depression, proper dosing and titration of Hydrocodone Bitartrate and Acetaminophen Tablets are essential [see WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of Hydrocodone Bitartrate and Acetaminophen Tablets especially by children, can result in a fatal overdose of Hydrocodone [see WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of Hydrocodone Bitartrate and Acetaminophen Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [See WARNINGS , PRECAUTIONS; DRUG INTERACTIONS ]. Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS ].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see WARNINGS ]. Cytochrome P450 3A4 Interaction The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in Hydrocodone Bitartrate and Acetaminophen Tablets plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.
In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in Hydrocodone Bitartrate and Acetaminophen Tablets plasma concentrations. Monitor patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets and any Cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [see CLINICAL PHARMACOLOGY , WARNINGS , PRECAUTIONS; Drug Interactions ]. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen containing product.[see WARNINGS , OVERDOSAGE ].
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at dosage or duration [see WARNINGS ], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone Bitartrate and Acetaminophen Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Hydrocodone Bitartrate and Acetaminophen Tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opiods and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Because the risk of overdose increases as opiod doses increase, reserve titration to higher doses of Hydrocodone Bitartrate and Acetaminophen Tablets for patients in who, lower doses are insufficiently effective and in who, the expected benefits of using a higher dose opiod clearly outweigh the substantial risks.
Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors.
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 [see WARNINGS ]. Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Hydrocodone Bitartrate and Acetaminophen Tablets. Consider this risk when selecting an initial dose and when making dose adjustments [see WARNINGS ].
Initial Dosage Use of Hydrocodone Bitartrate and Acetaminophen Tablets as the First Opioid Analgesic 5mg/325mg Initiate treatment with Hydrocodone Bitartrate and Acetaminophen Tablets in a dosing range of 1 to 2 tablets every 4 to 6 hours as needed for pain, at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets. The total daily dosage should not exceed 8 tablets.
7.5mg/325mg 10mg/325mg Initiate treatment with Hydrocodone Bitartrate and Acetaminophen Tablets 1 every 4 to 6 hours as needed for pain, at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets. The total daily dosage should not exceed 6 tablets.
Conversion from Other Opioids to Hydrocodone Bitartrate and Acetaminophen Tablets There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Hydrocodone Bitartrate and Acetaminophen Tablets. It is safer to underestimate a patient’s 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage than to overestimate the 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage and manage an adverse reaction due to overdose.
Conversion from Hydrocodone Bitartrate and Acetaminophen Tablets to Extended-Release Hydrocodone The relative bioavailability of hydrocodone from Hydrocodone Bitartrate and Acetaminophen Tablets compared to extended-release hydrocodone products is unknown, so conversion to extended-release products must be accompanied by close observation for signs of excessive sedation and respiratory depression. Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with Hydrocodone Bitartrate and Acetaminophen Tablets [see WARNINGS, Life-Threatening Respiratory Depression ; PRECAUTIONS, Information for Patients and/or Caregivers ].
Inform patients and caregivers abou…
⛔ Contraindications ▾
CONTRAINDICATIONS Hydrocodone Bitartrate and Acetaminophen Tablet is contraindicated in patients with: • Significant respiratory depression [see WARNINGS ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] • Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see WARNINGS , ADVERSE REACTIONS ]
⚠️ Warnings ▾
WARNINGS Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Acetaminophen Tablets contain hydrocodone, a Schedule II controlled substance. As an opioid, Hydrocodone Bitartrate and Acetaminophen Tablet exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ] . Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hydrocodone Bitartrate and Acetaminophen Tablets.
Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Hydrocodone Bitartrate and Acetaminophen Tablets and reassess all patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).
The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Hydrocodone Bitartrate and Acetaminophen Tablets but use in such patients necessitates intensive counseling about the risks and proper use of Hydrocodone Bitartrate and Acetaminophen Tablets along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose [see WARNINGS, Life-Threatening Respiratory Depression ; Dosage and Administration, Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose ] .
Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing Hydrocodone Bitartrate and Acetaminophen Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and proper disposal of unused drug.
Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.
Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see OVERDOSAGE ] . Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Hydrocodone Bitartrate and Acetaminophen Tablets, the risk is greatest during the initiation of therapy or following a dosage increase.
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of Hydrocodone Bitartrate and Acetaminophen Tablets. To reduce the risk of respiratory depression, proper dosing and titration of Hydrocodone Bitartrate and Acetaminophen Tablets is essential [see DOSAGE AND ADMINISTRATION ] . Overestimating the Hydrocodone Bitartrate and Acetaminophen Tablets dosage when converting patients from another opioid product can result in a fatal overdose.
Accidental ingestion of even one dose of Hydrocodone Bitartrate and Acetaminophen Tablets, especially by children, can result in respiratory depression and death due to an overdose of Hydrocodone Bitartrate and Acetaminophen Tablets. Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emerg…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of Hydrocodone Bitartrate and Acetaminophen Tablet. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting.
Other adverse reactions include Central Nervous System – Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes. Gastrointestinal System – Constipation. Genitourinary System – Ureteral spasm, spasm of vesical sphincters, and urinary retention.
Special Senses – Cases of Hearing impairment or permanent loss have been reported predominately in patients with chronic overdose. Dermatological – Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions Hematological – Thrombocytopenia, agranulocytosis. Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. • Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. • Anaphylaxis : Anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Tablets. • Androgen deficiency : Cases of androgen deficiency have occurred with chronic use of opioids for an extended period of time [see CLINICAL PHARMACOLOGY ].
Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see WARNINGS ]. Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).
🔄 Drug Interactions ▾
Drug Interactions Inhibitors of CYP3A4 and CYP2D6 The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of the Hydrocodone Bitartrate and Acetaminophen Tablets, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets and both CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Acetaminophen Tablets is achieved [see WARNINGS ].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the Hydrocodone Bitartrate and Acetaminophen Tablets plasma concentration will decrease [see CLINICAL PHARMACOLOGY ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Tablets. If concomitant use is necessary, consider dosage reduction of Hydrocodone Bitartrate and Acetaminophen 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 and Acetaminophen Tablets dosage until stable drug effects are achieved.Evaluate for signs or symptoms of opioid withdrawal. Inducers of CYP3A4 The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of Hydrocodone Bitartrate and Acetaminophen Tablets [see CLINICAL PHARMACOLOGY ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Tablets [see WARNINGS ].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the Hydrocodone Bitartrate and Acetaminophen Tablets plasma concentration will increase [see CLINICAL PHARMACOLOGY ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. If concomitant use is necessary, consider increasing the Hydrocodone Bitartrate and Acetaminophen Tablets dosage until stable drug effects are achieved. Evaluate the patient for signs and symptoms of opioid withdrawal.
If a CYP3A4 inducer is discontinued, consider Hydrocodone Bitartrate and Acetaminophen Tablets dosage reduction and follow for signs of respiratory depression. Benzodiazepines and Other CNS Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants, such as benzodiazepines and other sedative hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction, educate them on the signs and symptoms of respiratory depression (including sedation).
If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see WARNINGS ]. Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e.,…
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects There are no adequate and well-controlled studies in pregnant women. Hydrocodone Bitartrate and Acetaminophen Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity, abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see WARNINGS ].
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of Hydrocodone Bitartrate and Acetaminophen Tablets in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to Hydrocodone Bitartrate and Acetaminophen Tablets. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.
Titrate the dosage of Hydrocodone Bitartrate and Acetaminophen Tablets slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see WARNINGS ]. Hydrocodone and acetaminophen are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.
Hepatic Impairment Patients with hepatic impairment may have higher plasma hydrocodone concentrations than those with normal function. Use a low initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with hepatic impairment and regularly evaluate for adverse events such as respiratory depression and sedation. Renal Impairment Patients with renal impairment may have higher plasma hydrocodone concentrations than those with normal function.
Use a low initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with renal impairment and regularly evaluate for adverse events such as respiratory depression and sedation.
🆘 Overdosage ▾
OVERDOSAGE Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Clinical Presentation Acute overdosage with Hydrocodone Bitartrate and Acetaminophen Tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Acetaminophen Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise.
Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment of Overdose Hydrocodone In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.
Cardiac arrest or arrhythmias will require advanced life-support techniques. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to Opioid overdose, administer an opioid antagonist.
Because the duration of opioid reversal is expected to be less than the duration of action of Hydrocodone Bitartrate and Acetaminophen Tablets in Hydrocodone Bitartrate and Acetaminophen Tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome.
The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist. Acetaminophen Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation.
Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Hydrocodone is full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone.
Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions. Pharmacodynamics Effects on the Central Nervous System The principal therapeutic action of hydrocodone is analgesia. Hydrocodone produces respiratory depression by direct action on brain stem respiratory centers.
The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. Hydrocodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings).
Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Effects on the Gastrointestinal Tract and Other Smooth Muscle Hydrocodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.
Effects on the Cardiovascular System Hydrocodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see ADVERSE REACTIONS ].
They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Use of opioids for an extended periods of time may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see ADVERSE REACTIONS ].
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
Concentration–Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with agonist opioids. The minimum effective analgesic concentration of hydrocodone for any individual p…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as: Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5/325 Peach colored capsule shaped tablets, one side scored and other side debossed with “WES 301”. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 (NDC 71930-019-12) 500 (NDC 71930-019-52) and 1000 (NDC 71930-019-13).
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5/325 White colored capsule shaped tablets, one side scored and other side debossed with “WES 302”. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 (NDC 71930-020-12) 500 (NDC 71930-020-52) and 1000 (NDC 71930-020-13).
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10/325 Blue colored capsule shaped tablets, one side scored and other side debossed with “WES 303”. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 (NDC 71930-021-12) 500 (NDC 71930-021-52) and 1000 (NDC 71930-021-13).
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store Hydrocodone Bitartrate and Acetaminophen Tablets, USP securely and dispose of properly [see PRECAUTIONS / Information for Patients ].
Manufactured by: WES Pharma Inc Westminster, MD 21157 USA Distributed by: Eywa Pharma Inc 2 Research Way, Floor 3 Princeton, NJ 08540 Revised: 01/2024
📋 Description ▾
DESCRIPTION Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light.
The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non- salicylate analgesic and antipyretic. It has the following structural formula: Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg contains: Hydrocodone Bitartrate………………………..5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg contains: Hydrocodone Bitartrate………………………..7.5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg contains: Hydrocodone Bitartrate………………………..10 mg Acetaminophen……………………………….325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, FD&C yellow#6 aluminum lake (5 mg/325 mg only), and FD&C blue#1 aluminum lake (10 mg/325 mg only).
Meets USP Dissolution Test 2. hydroc-struct aceto-struct
💬 Information for Patients ▾
Information for Patients Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Hydrocodone Bitartrate and Acetaminophen Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving hydrocodone bitartrate and acetaminophen tablets unsecured can pose a deadly risk to others in the home.
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused Hydrocodone Bitartrate and Acetaminophen Tablets should be disposed of by flushing the unused medication down the toilet if a drug take -back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
Addiction, Abuse, and Misuse Inform patients that the use of Hydrocodone Bitartrate and Acetaminophen Tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ]. Instruct patients not to share Hydrocodone Bitartrate and Acetaminophen Tablets with others and to take steps to protect Hydrocodone Bitartrate and Acetaminophen Tablets from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Hydrocodone Bitartrate and Acetaminophen Tablets or when the dosage is increased, and that it can occur even at recommended dosages.
Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see WARNINGS , Life Threatening Respiratory Depression ]. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ] . Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Hydrocodone Bitartrate and Acetaminophen Tablets is used with benzodiazepines and other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS and PRECAUTIONS; Drug Interactions ].
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with Hydrocodone Bitartrate and Acetaminophen Tablets. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) [see WARNINGS , Life-Threatening Respiratory Depression ; DOSAGE AND ADMINISTRATION ].
Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered [see OVERDOSAGE ]. If naloxone is prescribed, also advise patients and caregivers: • How to treat with naloxone in the event of an opioid overdose • To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency • To read the Patient Information (or other educational material) that will come with their naloxone.
Emphasize the importance of doing this before an opioi…