What is NDC 0641-6259?

0641-6259 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride .2 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. 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 0641-6259

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6259Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6259Add 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
0641-6259-10	0064162591000641625910	10 SYRINGE in 1 CARTON (0641-6259-10) / 1 mL in 1 SYRINGE (0641-6259-01)Marketed from Apr 26, 2024

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 — .2 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216899
Marketing start: Apr 26, 2024
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0641-6259_2c21b807-cef3-4127-a395-37fae2a435c6SPL ID 2c21b807-cef3-4127-a395-37fae2a435c6SPL set ID 31d5a37a-0e90-4e88-be14-75c877be9de2RxCUI 897756, 897757, 1433251, 2277368UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400641625910 followed by a unit qualifier and the quantity

Package 00641-6259-10. 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 Jul 24, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Hydromorphone hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitation 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 injection 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 injection is an opioid agonist indicated for …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0641-6259

What is NDC 0641-6259?: 0641-6259 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride .2 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. 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 .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
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 4 mg/1	TabletOral	American Health Packaging	60687-590	60687-0590-01

All 65 Hydromorphone Hydrochloride NDCs

Other NDCs under ANDA 216899

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

FDA NDC Directory listings under ANDA 216899
Product	Strength	Form · route	Labeler	Product NDC
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6169
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6170
Hydromorphone Hydrochloride	Hydromorphone hydrochloride .5 mg/.5mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6206