The ALV 196 blue pill is a generic oxycodone/acetaminophen tablet at 5 mg/325 mg strength made by Alvogen, used for pain severe enough to require an opioid when alternatives are inadequate, and it is a Schedule II controlled substance with a high potential for abuse. In pill identifiers and FDA labeling, it appears as a blue, round, approximately 11 mm tablet debossed “ALV 196,” corresponding to NDC codes under 47781-196, and is available only by prescription.
What is ALV 196?
The imprint “ALV 196” identifies a blue, round oxycodone/acetaminophen tablet containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen, which is the same active combination as branded Percocet 5/325 mg in a generic form supplied by Alvogen.
It belongs to the narcotic analgesic combinations drug class and is indicated for the management of pain severe enough to require an opioid and for which alternative treatments are inadequate. This product is DEA Schedule CII due to the abuse and dependence potential of oxycodone and is dispensed only by prescription.
Pill identification
Legitimate ALV 196 tablets are blue, round, about 11.00 mm in diameter, and carry the debossed imprint “ALV 196,” with a bisect separating the components on the same face per FDA labeling. The labeler/supplier is Alvogen, Inc., with National Drug Code variations including 47781-196-01, -05, and -63 for different package sizes, aligning with Drugs.com’s listing of NDC 47781-0196 for the imprint entry. The 5/325 mg tablet uses FD&C Blue No. 1 Aluminum Lake as the colorant; other strengths are color coded differently by the manufacturer.
| Feature | Details |
|---|---|
| Imprint | ALV 196 |
| Strength | 5 mg oxycodone HCl / 325 mg acetaminophen |
| Color | Blue (FD&C Blue No. 1) |
| Shape/Size | Round, ~11 mm |
| Score | Debossed “ALV” and “196” separated by a bisect on one side |
| Drug class | Narcotic analgesic combinations; DEA Schedule II |
| Labeler | Alvogen, Inc. |
| NDCs | 47781-196-01/-05/-63; Drugs.com imprint entry 47781-0196 |
Ingredients
Each tablet contains 5 mg oxycodone hydrochloride (equivalent to 4.4815 mg oxycodone base) and 325 mg acetaminophen as active ingredients. Inactive ingredients for Alvogen’s tablets include crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, stearic acid, and for 5/325 mg specifically, FD&C Blue No. 1 Aluminum Lake, with minor excipient variation possible between sources
How it works
Oxycodone is a full mu‑opioid receptor agonist providing analgesia without a pharmacologic ceiling effect, with dose titration limited by adverse effects such as sedation and respiratory depression. Acetaminophen provides analgesic and antipyretic effects through central mechanisms, augmenting oxycodone’s pain relief to reduce required opioid dose in appropriate patients.
Approved uses
This combination is indicated for pain severe enough to require an opioid analgesic and for which non‑opioid options were not tolerated or did not provide adequate analgesia, and use should be limited to the shortest duration and lowest effective dose consistent with individual goals.
It should not be used for extended periods unless pain remains severe enough to require an opioid and alternatives continue to be inadequate.
Dosing and administration
For the 5/325 mg strength (equivalent to ALV 196), common adult directions for Percocet 5/325 are 1 tablet every 6 hours as needed, with prescriber adjustments as necessary and a typical maximum not exceeding 12 tablets per day, but always follow the specific prescription instructions provided.
The total daily acetaminophen from all sources must not exceed 4,000 mg per day to reduce the risk of severe liver injury, and all other medicines should be checked to avoid duplicating acetaminophen (APAP/Tylenol).
Boxed warnings and serious risks
There are boxed warnings for addiction, abuse, and misuse that can lead to overdose and death even at recommended doses, requiring ongoing risk assessment and patient counseling under the Opioid Analgesic REMS program.
Life‑threatening respiratory depression can occur, especially at initiation or dose increase, and concomitant use with benzodiazepines, alcohol, or other CNS depressants can cause profound sedation, respiratory depression, coma, and death.
Additional boxed warnings and critical cautions include neonatal opioid withdrawal syndrome with prolonged use in pregnancy, CYP3A4 inhibitor/inducer interactions affecting oxycodone levels, and acetaminophen hepatotoxicity particularly when exceeding 4,000 mg/day or combining APAP products.
Contraindications and precautions
This product is contraindicated in significant respiratory depression, acute or severe bronchial asthma in unmonitored settings, known or suspected GI obstruction including paralytic ileus, and hypersensitivity to components.
Use requires extra caution in elderly, cachectic, or debilitated patients; those with chronic pulmonary disease, head injury, increased intracranial pressure, seizure disorders, biliary tract disease, or adrenal insufficiency risk, among others noted in labeling and clinical guidance.
Common side effects
Common or notable adverse effects include dizziness, drowsiness, nausea, constipation, pruritus, hypotension, and in serious cases respiratory depression, with multiple additional effects cataloged in clinical references and the FDA label.
Signs of severe hepatotoxicity from acetaminophen can include right upper quadrant pain, jaundice, dark urine, and pale stools, and warrant immediate medical care.
Drug interactions to avoid
Avoid or carefully manage concurrent CNS depressants including benzodiazepines and alcohol due to additive respiratory and sedative risks, and consider naloxone access based on individual risk factors. Clinically significant CYP3A4 interactions occur with inhibitors (e.g., ketoconazole, ritonavir) and inducers (e.g., rifampin, carbamazepine, phenytoin), requiring close monitoring and dose adjustment to prevent overdose or withdrawal, respectively. Do not use with MAO inhibitors within 14 days, and avoid grapefruit juice due to interaction potential noted in clinical guidance.
Overdose and emergency guidance
Opioid overdose can present with extreme sleepiness, pinpoint pupils, slow or shallow breathing, or loss of consciousness, and requires immediate emergency care and naloxone when available given its temporary reversal of opioid effects.
Educate household members on recognizing respiratory depression and using naloxone, and always contact emergency services because naloxone’s duration may be shorter than the opioid effect.
Storage and safe disposal
Store securely at room temperature in a closed container out of sight and reach of children to prevent accidental ingestion, misuse, or theft, as even one dose can be fatal to a child. Dispose of unused tablets at a drug take‑back site when possible, or flush if no take‑back option is readily available, per FDA and REMS guidance for opioids.
Counterfeit pill warning
The DEA has warned of increasing overdose deaths tied to counterfeit pills that mimic prescription opioids but contain fentanyl or other dangerous substances, underscoring the importance of using only pharmacy‑dispensed medication from a valid prescription.
Because Percocet‑like tablets appear in multiple colors and imprints, counterfeit risks exist, and verification of imprint, source, and NDC‑matched packaging is essential for safety.
Frequently asked questions
- Is ALV 196 the same as Percocet 5/325? Yes, ALV 196 is a generic version of oxycodone/acetaminophen 5/325 mg (Percocet strength) supplied by Alvogen, with therapeutically equivalent active ingredients.
- Can the ALV 196 tablet be split? The 5/325 blue tablet is debossed with a bisect alongside the “ALV 196” imprint, but splitting should only be done if specifically directed by a prescriber to ensure accurate dosing and safety.
- How can legitimacy be verified? Check the imprint (ALV 196), color and shape, manufacturer (Alvogen), and NDCs beginning 47781‑196 on labeled packaging, and obtain medication only from licensed pharmacies to avoid counterfeits.
Bottom line
The ALV 196 blue pill is the 5 mg/325 mg generic oxycodone/acetaminophen tablet by Alvogen for severe pain where non‑opioids are inadequate, and it carries boxed warnings for addiction, respiratory depression, hazardous interactions, and acetaminophen hepatotoxicity that require careful prescribing and patient education under the opioid REMS framework. Accurate identification, strict adherence to dosing (including a total daily acetaminophen limit of 4,000 mg), safe storage, and proper disposal are central to safe use, and any suspected overdose or counterfeit exposure warrants immediate emergency action.