Hydromorphone Hydrochloride NDC 42858-304

NDC codes

FDA NDC Directory

Product NDC (as listed)42858-304Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42858-0304Add 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
42858-304-16	42858030416	473 mL in 1 BOTTLE, PLASTIC (42858-304-16)Marketed from Jul 20, 2012

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): Hydromorphone Hydrochloride
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 authorized genericApplication NDA 019891
Marketing start: Jul 20, 2012
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 42858-304_b786b01b-46f9-4a00-a667-699e813a741bSPL ID b786b01b-46f9-4a00-a667-699e813a741bSPL set ID 37565441-0d95-4743-a695-d7b3326f58a1RxCUI 897657, 897696, 897702, 897710UNII L960UP2KRWUPC 0342858303019
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

N442858030416 followed by a unit qualifier and the quantity

Package 42858-0304-16. 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)

Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) 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, includi…

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
Dilaudidhydromorphone hydrochloride	Hydromorphone hydrochloride 5 mg/5mL	SolutionOral	Rhodes Pharmaceuticals LLC	42858-416