Prescription medicine
Hydrocodone and ibuprofen First approved as Vicoprofen
Hydrocodone and ibuprofen (Vicoprofen) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $0.487 per unit (Hydrocodone-ibuprofen 7.5-200) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the hydrocodone and ibuprofen FDA label on DailyMed (effective November 21, 2025, Amneal Pharmaceuticals of New York LLC); the NDA 20716 record on Drugs@FDA; every hydrocodone and ibuprofen label on DailyMed.
Highlights of the record
FDA label of November 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS.
Addiction, Abuse, and Misuse Because the use of hydrocodone bitartrate and ibuprofen 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 ibuprofen, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydrocodone bitartrate and ibuprofen are essential (see WARNINGS ). Accidental Ingestion Accidental ingestion of even one dose of hydrocodone bitartrate and ibuprofen, 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. […]
Used for
From the label: indications and usageHydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Forms and strengths
- 2.5 mg / 200 mg
- 5 mg / 200 mg
- 7.5 mg / 200 mg
- 10 mg / 200 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- September 23, 1997 Vicoprofen, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first April 11, 2003; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.487 per unit Hydrocodone-ibuprofen 7.5-200
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 467 through July 30, 2026
What is hydrocodone and ibuprofen used for?
From the label: indications and usageHydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation ). […]
Conditions named in the indications of hydrocodone and ibuprofen's FDA labels, with every medicine labeled for each:
From other hydrocodone and ibuprofen labelsPain: INDICATIONS AND USAGE Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug and Opioid Agonist.
Source: FDA drug label (Hydrocodone Bitartrate and Ibuprofen), Amneal Pharmaceuticals of New York LLC, effective November 21, 2025 (SPL set abc33718-4e88-43ea-9ffa-2b04ffc812ef), via openFDA; the full label on DailyMed
Is there a generic for hydrocodone and ibuprofen (Vicoprofen)?
The FDA approved the first generic hydrocodone and ibuprofen on April 11, 2003. 7 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists hydrocodone and ibuprofen from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2003 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydrocodone and ibuprofen (Vicoprofen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.487 per unit (Hydrocodone-ibuprofen 7.5-200), up 1% from $0.482 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Hydrocodone-ibuprofen 7.5-200 (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydrocodone-ibuprofen 10-200 | Generic | $3.36 per unit | n/a | -1% |
| Hydrocodone-ibuprofen 5-200 mg | Generic | $2.57 per unit | n/a | -4% |
| Hydrocodone-ibuprofen 7.5-200 | Generic | $0.487 per unit | n/a | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the hydrocodone and ibuprofen label say about other medicines?
The hydrocodone and ibuprofen label names 14 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications | History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. |
| Buprenorphine | warnings | Additionally, avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including hydrocodone bitartrate and ibuprofen. |
| Butorphanol | warnings | Additionally, avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including hydrocodone bitartrate and ibuprofen. |
| Carbamazepine | warnings | Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in hydrocodone bitartrate and ibuprofen-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions. |
| Erythromycin | warnings | Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers Concomitant use of hydrocodone bitartrate and ibuprofen with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may … |
| Gabapentin | warnings | … non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids). |
| Ketoconazole | warnings | Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers Concomitant use of hydrocodone bitartrate and ibuprofen with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may … |
| Nalbuphine | warnings | Additionally, avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including hydrocodone bitartrate and ibuprofen. |
| Nalmefene | 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). |
| Naloxone | 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). |
| Phenytoin | warnings | Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in hydrocodone bitartrate and ibuprofen-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions. |
| Pregabalin | warnings | … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids). |
| Rifampin | warnings | Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in hydrocodone bitartrate and ibuprofen-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions. |
| Ritonavir | warnings | … antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of hydrocodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression (see WARNINGS: |
Source: FDA drug label (Hydrocodone Bitartrate and Ibuprofen), Amneal Pharmaceuticals of New York LLC, effective November 21, 2025 (SPL set abc33718-4e88-43ea-9ffa-2b04ffc812ef), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrocodone and ibuprofen?
The FDA Adverse Event Reporting System holds 467 reports that list hydrocodone and ibuprofen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 82 are coded as a death and 37 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as hydrocodone and ibuprofen?
39 other medicines are given the same way (oral) and in the same FDA class as hydrocodone and ibuprofen or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Naproxen | Pain | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Pain | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Pain | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Acetaminophen and aspirin and caffeine | Pain | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Meloxicam | Pain | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
Every medicine labeled for the same conditions as hydrocodone and ibuprofen
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to hydrocodone and ibuprofen
- 39 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Hydrocodone and ibuprofen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other