Hydrocodone Bitartrate and Acetaminophen 5 mg; 325 mg Tablet, 100-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 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
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
-
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $0.139 | $13.85 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3561 | $35.61 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2311 | $23.11 / 100 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; 5 mg 42806-0111-01 | Epic | 100 tablets | $0.107 | AA | FDA listed | save 23% |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 43386-0356-01 | Lupin | 100 tablets | $0.135 | — | Availability likely | save 2% |
| Hydrocodone Bitartrate And Acetaminophen 5 mg/1; 325 mg 00406-0123-01 | SpecGx | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 10702-0189-01 | KVK-Tech, | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 13107-0019-01 | Aurolife | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 27808-0035-01 | Cranbury | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 31722-0996-01 | Camber | 100 tablets | $0.138 | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 42858-0201-01 | Rhodes | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 50268-0401-15 | AvPAK | 50 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mgthis 53746-0109-01 | Amneal | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 60687-0396-01 | American | 100 tablets | $0.138 | AA | Availability likely | — |
| hydrocodone bitartrate and acetaminophen 5 mg/1; 325 mg 64380-0440-01 | Strides | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 64850-0631-01 | Elite | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 70010-0672-01 | Granules | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71930-0019-12 | Eywa | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 00245-0410-01 | Upsher-Smith | 100 tablets | — | — | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 5 mg/1; 325 mg 50090-1778-00 | A-S | 20 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 5 mg/1; 325 mg 55700-0992-14 | Quality | 14 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate And Acetaminophen 5 mg/1; 325 mg 60429-0590-01 | Golden | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 5 mg/1; 325 mg 60760-0870-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 60760-0873-60 | St. | 60 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63187-0112-15 | Proficient | 15 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63187-0375-12 | Proficient | 12 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63629-1939-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63629-2292-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63629-2293-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63629-2294-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63629-2468-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63629-5422-00 | Bryant | 10 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63629-8499-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 63629-8885-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 5 mg/1; 325 mg 67296-1890-09 | RedPharm | 40 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 67296-2201-01 | Redpharm | 4 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 68071-3447-03 | NuCare | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 68071-3685-06 | NuCare | 6 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 68071-4801-02 | NuCare | 12 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 68071-4853-02 | NuCare | 20 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-1417-00 | Bryant | 10 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-1470-01 | Bryant | 21 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-1811-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-2103-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-2116-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-2117-00 | Bryant | 10 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-2144-00 | Bryant | 10 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-2195-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-2585-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-2969-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 71335-9734-00 | Bryant | 10 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 72162-1279-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 72162-1341-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 72162-1989-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 5 mg/1; 325 mg 72189-0343-08 | Direct | 8 tablets | — | AA | FDA listed | — |
| Hydrocodone/APAP 325 mg/1; 5 mg 72189-0407-60 | Direct_Rx | 60 tablets | — | AA | FDA listed | — |
| Hydrocodone/APAP 5 mg/1; 325 mg 72189-0649-20 | Direct_Rx | 20 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 72865-0110-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 72865-0202-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 76420-0133-30 | Asclemed | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 76420-0875-00 | Asclemed | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 5 mg/1; 325 mg 82804-0116-12 | Proficient | 12 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 5 mg/1; 325 mg 87063-0049-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| hydrocodone bitartrate and acetaminophen 5 mg/1; 325 mg 82804-0306-12 | Proficient | 12 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 |
|---|---|---|---|---|---|
| 53746-0109-01 You're viewing this | 100 TABLET in 1 BOTTLE (53746-109-01) | $0.1385 / ea | $13.85 | 2010-01-18 | Active |
| 53746-0109-05 | 500 TABLET in 1 BOTTLE (53746-109-05) | $0.1385 / ea | $69.23 | 2010-01-18 | Active |
| 53746-0109-10 | 1000 TABLET in 1 BOTTLE (53746-109-10) | $0.1019 / ea | $101.89 | 2010-01-18 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Per ea, this pack runs about 36% above the cheapest pack (1000-count, $0.1019 vs $0.1385 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 93% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 53746-0109-01?
What is the difference between NDC 53746-0109-01 and NDC 53746-0109-05?
What NDC number is used to bill for this package of Hydrocodone Bitartrate and Acetaminophen 5 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 HYDROCODONE 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) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, 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 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 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 Tablets are 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
⏱️ 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 opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see WARNINGS ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Hydrocodone Bitartrate and Acetaminophen 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.
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 ].
Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
The presence of risk factors for overdose should not prevent the management of pain in any patient [see WARNINGS; Addiction, Abuse, and Misuse ; Life-Threatening Respiratory Depression ; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants ]. Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program). There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics.
Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent. Initial Dosage Use of Hydrocodone Bitartrate and Acetaminophen Tablets as the First Opioid Analgesic 5 mg/325 mg 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. 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 a…
⛔ Contraindications ▾
CONTRAINDICATIONS Hydrocodone Bitartrate and Acetaminophen Tablets are 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 Tablets 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. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [ ADVERSE REACTIONS ].
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 and 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 recommending or prescribing an opioid overdose reversal agent [see WARNINGS , DOSAGE AND ADMINISTRATION ]. 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 [see PRECAUTIONS; Information for Patients ]. 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 overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient’s clinical status [see OVERDOSAGE ].
Carbon dioxide (CO 2 ) 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. To reduce the risk of respiratory depression, proper dosing and titration of Hydrocodone Bitartrate and Acetaminophen Tablets are 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 r…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of Hydrocodone Bitartrate and Acetaminophen Tablets. 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 predominantly 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 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). Opioid-induced esophageal dysfunction (OIED): Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term [see WARNINGS ]. Adverse Reactions from Observational Studies A prospective, observational cohort study estimated the risks of addiction, abuse, and misuse in patients initiating long-term use of Schedule II opioid analgesics between 2017 and 2021.
Study participants included in one or more analyses had been enrolled in selected insurance plans or health systems for at least one year, were free of at least one outcome at baseline, completed a minimum number of follow-up assessments, and either: 1) filled multiple extended-release/long-acting opioid analgesic prescriptions during a 90-day period (n=978); or 2) filled any Schedule II opioid analgesic prescriptions covering at least 70 of 90 days (n=1,244). Those included also had no dispensing of the qualifying opioids in the previous 6 months.
Over 12 months: approximately 1% to 6% of participants across the two cohorts newly met criteria for addiction, as assessed with two validated interview-based measures of moderate-to-severe opioid use disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, and approximately 9% and 22% of participants across the two cohorts newly met criteria for prescription opioid abuse and misuse [defined in DRUG ABUSE AND DEPENDENCE ], respectively, as measured with a validated self-reported instrument.
A retrospective, observational cohort study estimated the risk of opioid-involved overdose or opioid overdose-related death in patients with new long-term use of Schedule II opioid analgesics from 2006 through 2016 (n=220,249). Included patients had been enrolled in either one of two commercial insurance programs, one managed care program, or one Medicaid program for at least 9 months. New long-term use was defined as having Schedule I…
🆘 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 [see CLINICAL PHARMACOLOGY ].
Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. 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 measures. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene.
Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone in Hydrocodone Bitartrate and Acetaminophen Tablets, frequently evaluate the patient until spontaneous respiration is reliably reestablished. If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the overdose reversal agent 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 reversal agent administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the reversal agent should be initiated with care and by titration with smaller than usual doses of the reversal agent. 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, transient elevations in serum amylase, and opioid-induced esophageal dysfunction (OIED).
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 period 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 opioid agonists. The minimum effective analgesic conc…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg , are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 109” on obverse and bisected on the reverse. Each tablet contains 5 mg hydrocodone bitartrate, USP and 325 mg acetaminophen, USP. They are available as follows: Bottles of 100: NDC 53746-109-01 Bottles of 500: NDC 53746-109-05 Bottles of 1,000: NDC 53746-109-10 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. A Schedule II Narcotic DEA Order Form Required. Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS ; Information for Patients ].
Manufactured by: Amneal Pharmaceuticals of NY, LLC Brookhaven, NY 11719 Rev. 10-2025-15
📋 Description ▾
DESCRIPTION Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate, USP 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, USP, 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, USP ......
5 mg Acetaminophen, USP ................. 325 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. This product complies with USP dissolution test 1.
Structure Structure 2
💬 Medication Guide ▾
Medication Guide Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and Acetaminophen (a seet” a min’ oh fen) Tablets CII Hydrocodone Bitartrate and Acetaminophen Tablets are: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. An opioid pain medicine that can put you at risk for overdose and death.
Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Important information about Hydrocodone Bitartrate and Acetaminophen Tablets: Get emergency help or call 911 right away if you take too much Hydrocodone Bitartrate and Acetaminophen Tablets (overdose). When you first start taking Hydrocodone Bitartrate and Acetaminophen Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. Taking Hydrocodone Bitartrate and Acetaminophen Tablets with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin) alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your Hydrocodone Bitartrate and Acetaminophen Tablets.
They could die from taking it. Selling or giving away Hydrocodone Bitartrate and Acetaminophen Tablets is against the law. 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.
Do not take Hydrocodone Bitartrate and Acetaminophen Tablets if you have: Severe asthma, trouble breathing, or other lung problems. A bowel blockage or have narrowing of the stomach or intestines. Known hypersensitivity to hydrocodone bitartrate or acetaminophen, or any ingredient in Hydrocodone Bitartrate and Acetaminophen Tablets.
Before taking Hydrocodone Bitartrate and Acetaminophen Tablets, tell your healthcare provider if you have a history of: head injury, seizures problems urinating abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems liver, kidney, thyroid problems pancreas or gallbladder problems Tell your healthcare provider if you are: Noticing your pain getting worse. If your pain gets worse after you take Hydrocodone Bitartrate and Acetaminophen Tablets, do not take more of Hydrocodone Bitartrate and Acetaminophen Tablets without first talking to your healthcare provider.
Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Hydrocodone Bitartrate and Acetaminophen Tablets. Are pregnant or planning to become pregnant. Use of Hydrocodone Bitartrate and Acetaminophen Tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
Breast feeding. Hydrocodone Bitartrate and Acetaminophen passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness.
Seek immediate medical care if you notice these signs. Living in a household where there are small children or someone who has abused street or prescription drugs. Taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
Taking Hydrocodone Bitartrate and Acetaminophen Tablets with certain other medicines can cause serious side effects that could lead to death. When taking Hydrocodone Bitartrate and Acetaminophen Tablets: Do not change your dose.…