What is NDC 0574-0297?

0574-0297 is the product NDC for hydromorphone hydrochloride, Hydromorphone hydrochloride 32 mg/1 tablet, extended release, listed with the FDA by Padagis US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for hydromorphone hydrochloride?

66 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

hydromorphone hydrochloride NDC 0574-0297

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-0297Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-0297Add 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
0574-0297-01	00574029701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0297-01)Marketed from Sep 29, 2017

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 — 32 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Padagis US LLCNDC labeler code 0574
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204278
Marketing start: May 22, 2015
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0574-0297_8b576b81-17fc-4251-acc3-6e1b9e18030cSPL ID 8b576b81-17fc-4251-acc3-6e1b9e18030cSPL set ID 780a2616-0392-4715-bc50-71799bea1957RxCUI 902729, 902736, 902741, 1306898UNII L960UP2KRW
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

N400574029701 followed by a unit qualifier and the quantity

Package 00574-0297-01. 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 Dec 22, 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0574-0297

What is NDC 0574-0297?: 0574-0297 is the product NDC for hydromorphone hydrochloride, Hydromorphone hydrochloride 32 mg/1 tablet, extended release, listed with the FDA by Padagis US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: hydromorphone hydrochloride.
What is the active ingredient?: Hydromorphone hydrochloride.
Who is the labeler?: Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for hydromorphone hydrochloride?: 66 other product NDCs are listed under this name. See all hydromorphone hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other hydromorphone hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 4 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-998	60760-0998-60
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6254	00641-6254-01
Hydromorphone Hydrochloride	Hydromorphone hydrochloride .5 mg/.5mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6206	00641-6206-10
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6169	00641-6169-10
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6170	00641-6170-10
Hydromorphone Hydrochloride	Hydromorphone hydrochloride .2 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6259	00641-6259-10
Hydromorphone Hydrochloride	Hydromorphone hydrochloride .25 mg/.5mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hospira, Inc.	0409-1805	00409-1805-01
Hydromorphone Hydrochloride	Hydromorphone hydrochloride .5 mg/.5mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hospira, Inc.	0409-4264	00409-4264-01
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 5 mg/5mL	SolutionOral	American Health Packaging	60687-566	60687-0566-86
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/1	TabletOral	American Health Packaging	60687-579	60687-0579-01

All 67 hydromorphone hydrochloride NDCs

Other NDCs under ANDA 204278

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

FDA NDC Directory listings under ANDA 204278
Product	Strength	Form · route	Labeler	Product NDC
hydromorphone hydrochloride	Hydromorphone hydrochloride 8 mg/1	Tablet, Extended releaseOral	Padagis US LLC	0574-0293
hydromorphone hydrochloride	Hydromorphone hydrochloride 12 mg/1	Tablet, Extended releaseOral	Padagis US LLC	0574-0294
hydromorphone hydrochloride	Hydromorphone hydrochloride 16 mg/1	Tablet, Extended releaseOral	Padagis US LLC	0574-0295