Hydromorphone Hydrochloride NDC 0406-3244

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-3244Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-3244Add 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
0406-3244-01	00406324401	100 TABLET in 1 BOTTLE (0406-3244-01)Marketed from Dec 23, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076855
Marketing start: Dec 23, 2004
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0406-3244_914c9f88-d1ae-4b14-a18a-e1767ebb5c40SPL ID 914c9f88-d1ae-4b14-a18a-e1767ebb5c40SPL set ID 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2RxCUI 897696, 897702, 897710UNII L960UP2KRWUPC 0031100000010
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

N400406324401 followed by a unit qualifier and the quantity

Package 00406-3244-01. 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 Jul 2, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Hydromorphone hydrochloride 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 hydromorphone hydrochloride 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. Hydromorphone hydrochloride tablets contain hydromorphone, an opioid agon…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076855

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

FDA NDC Directory listings under ANDA 076855
Product	Strength	Form · route	Labeler	Product NDC
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/1	TabletOral	American Health Packaging	60687-579
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 4 mg/1	TabletOral	American Health Packaging	60687-590
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/1	TabletOral	SpecGx LLC	0406-3243
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 8 mg/1	TabletOral	SpecGx LLC	0406-3249
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/1	TabletOral	Redpharm Drug	67296-1414