What is NDC 72865-168?

72865-168 is the product NDC for hydromorphone hydrochloride, Hydromorphone hydrochloride 8 mg/1 tablet, extended release, listed with the FDA by XLCare Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

XLCare Pharmaceuticals, Inc., NDC labeler code 72865. 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?

64 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 72865-168

NDC codes

FDA NDC Directory

Product NDC (as listed)72865-168Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72865-0168Add 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
72865-168-01	72865016801	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-168-01)Marketed from Sep 24, 2020

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 — 8 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: XLCare Pharmaceuticals, Inc.NDC labeler code 72865
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212133
Marketing start: Sep 24, 2020
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72865-168_55fb6272-5677-43cf-b92d-5a6a6f484b6eSPL ID 55fb6272-5677-43cf-b92d-5a6a6f484b6eSPL set ID 90bda45c-9dbe-4ed5-91d0-df8446ad7026RxCUI 902729, 902736, 902741, 1306898UNII L960UP2KRWUPC 0372865168011, 0372865171011, 0372865170014, 0372865169018
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

N472865016801 followed by a unit qualifier and the quantity

Package 72865-0168-01. 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 Jan 17, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. 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, and misuse with opioids, which can occur at any dosage…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72865-168

What is NDC 72865-168?: 72865-168 is the product NDC for hydromorphone hydrochloride, Hydromorphone hydrochloride 8 mg/1 tablet, extended release, listed with the FDA by XLCare Pharmaceuticals, Inc.. 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?: XLCare Pharmaceuticals, Inc., NDC labeler code 72865. 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?: 64 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 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 .5 mg/.5mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6206	00641-6206-10
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 65 hydromorphone hydrochloride NDCs

Other NDCs under ANDA 212133

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

FDA NDC Directory listings under ANDA 212133
Product	Strength	Form · route	Labeler	Product NDC
hydromorphone hydrochloride	Hydromorphone hydrochloride 8 mg/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-119
hydromorphone hydrochloride	Hydromorphone hydrochloride 12 mg/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-120
hydromorphone hydrochloride	Hydromorphone hydrochloride 16 mg/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-121
hydromorphone hydrochloride	Hydromorphone hydrochloride 32 mg/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-122
hydromorphone hydrochloride	Hydromorphone hydrochloride 12 mg/1	Tablet, Extended releaseOral	XLCare Pharmaceuticals, Inc.	72865-169
hydromorphone hydrochloride	Hydromorphone hydrochloride 16 mg/1	Tablet, Extended releaseOral	XLCare Pharmaceuticals, Inc.	72865-170
hydromorphone hydrochloride	Hydromorphone hydrochloride 32 mg/1	Tablet, Extended releaseOral	XLCare Pharmaceuticals, Inc.	72865-171