FDA label
What is Dilaudid used for?
Dilaudid contains hydromorphone. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “DILAUDID Oral Solution and DILAUDID Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
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Dilaudid, tablet
Indications and Usage, quoted from the label by Rhodes Pharmaceuticals LLC (NDA019892). Cross-references to other label sections are left out.
DILAUDID Oral Solution and DILAUDID 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, reserve opioid analgesics, including DILAUDID Oral Solution and DILAUDID 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.
Source: DailyMed label, set id d6b40e39-a57e-402c-b4f6-7041e832f837, version 12, effective May 14, 2026. NDC 42858-122, one of 3 listings for this product.
Dilaudid, injection, solution
Indications and Usage, quoted from the label by Fresenius Kabi USA, LLC (NDA019034). Cross-references to other label sections are left out.
DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate 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, reserve opioid analgesics, including DILAUDID INJECTION for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 9eebd88a-5632-460f-b7b6-26c8a180540d, version 6, effective July 15, 2026. NDC 76045-009, one of 3 listings for this product.
Questions
What is Dilaudid used for?
The FDA label says: “DILAUDID Oral Solution and DILAUDID Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
What drug class is Dilaudid?
FDA lists hydromorphone in the Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Dilaudid
- Is Dilaudid a controlled substance?Schedule II
- Generic for DilaudidFDA Orange Book
- What is Hydromorphone used for?FDA label uses
- Is Hydromorphone a controlled substance?Schedule II
- Generic for Dilaudid-hpFDA Orange Book
- Generic for ExalgoFDA Orange Book
- Opioid Agonists listFDA drug class
- NDC 42858-122Dilaudid NDC record
- NDC 42858-234Dilaudid NDC record
- NDC 42858-338Dilaudid NDC record
- Schedule II drugs listDEA schedule