Hydromorphone Hydrochloride NDC 13811-704

NDC codes

FDA NDC Directory

Product NDC (as listed)13811-704Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13811-0704Add 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
13811-704-10	13811070410	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-704-10)Marketed from Sep 15, 2016

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 — 32 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Trigen Laboratories, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205629
Marketing start: Sep 15, 2016
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 13811-704_e22a1e07-ff84-4ef1-b154-804b49dcd52fSPL ID e22a1e07-ff84-4ef1-b154-804b49dcd52fSPL set ID 8bb81796-6990-40e9-bee4-1f292f91ae99RxCUI 902729, 902736, 902741, 1306898, 2706360UNII L960UP2KRWUPC 0313811701104, 0313811703108, 0313811704105, 0313811702101
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

N413811070410 followed by a unit qualifier and the quantity

Package 13811-0704-10. 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 Dec 25, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Hydromorphone hydrochloride extended-release tablets are indicated in opioid-tolerant patients for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and de…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205629

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

FDA NDC Directory listings under ANDA 205629
Product	Strength	Form · route	Labeler	Product NDC
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 12 mg/1	Tablet, Extended releaseOral	Trigen Laboratories, LLC	13811-702
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 8 mg/1	Tablet, Extended releaseOral	Trigen Laboratories, LLC	13811-701
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 16 mg/1	Tablet, Extended releaseOral	Trigen Laboratories, LLC	13811-703