Dilaudid (hydromorphone hydrochloride) NDC 42858-416

NDC codes

FDA NDC Directory

Product NDC (as listed)42858-416Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42858-0416Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42858-416-16	42858041616	473 mL in 1 BOTTLE, PLASTIC (42858-416-16)Marketed from May 15, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Dilaudid
Generic name (nonproprietary): hydromorphone hydrochloride
Active ingredients: Hydromorphone hydrochloride — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Rhodes Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019891
Marketing start: May 15, 2017
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 42858-416_3348b431-907c-4f1d-8a18-e4be2a04df23SPL ID 3348b431-907c-4f1d-8a18-e4be2a04df23SPL set ID d6b40e39-a57e-402c-b4f6-7041e832f837RxCUI 897657, 897658, 897696, 897698, 897702, 897704, 897710, 897712UNII L960UP2KRWUPC 0342858122016
Pharmacologic class: Opioid Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442858041616 followed by a unit qualifier and the quantity

Package 42858-0416-16. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective May 14, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

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 [see Warnings and Precautions (5.2) ] , 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. DILAUDID Oral Solution and DILAUDID Tablets contain hydrom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019891

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019891
Product	Strength	Form · route	Labeler	Product NDC
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 5 mg/5mL	SolutionOral	American Health Packaging	60687-566
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 5 mg/5mL	SolutionOral	Rhodes Pharmaceuticals LLC	42858-304