Dilaudid (hydromorphone hydrochloride) NDC 76045-121

NDC codes

FDA NDC Directory

Product NDC (as listed)76045-121Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76045-0121Add 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
76045-121-11	76045012111	10 SYRINGE in 1 CARTON (76045-121-11) / 1 mL in 1 SYRINGE (76045-121-01)Marketed from Jan 16, 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): Dilaudid
Generic name (nonproprietary): hydromorphone hydrochloride
Active ingredients: Hydromorphone hydrochloride — .2 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019034
Marketing start: Dec 16, 2016
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 76045-121_002d5650-24df-4b60-a5ce-e7adc091026fSPL ID 002d5650-24df-4b60-a5ce-e7adc091026fSPL set ID 9eebd88a-5632-460f-b7b6-26c8a180540dRxCUI 897756, 897757, 1433251, 1872265, 1872269, 1872752, 2277368, 2277370UNII 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

N476045012111 followed by a unit qualifier and the quantity

Package 76045-0121-11. 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 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate 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 DILAUDID 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. DILAUDID INJECTION is an opioid agonist indicated for the management of pain severe enough to require an op…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019034

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

FDA NDC Directory listings under NDA 019034
Product	Strength	Form · route	Labeler	Product NDC
Dilaudidhydromorphone hydrochloride	Hydromorphone hydrochloride 2 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Fresenius Kabi USA, LLC	76045-010
Dilaudidhydromorphone hydrochloride	Hydromorphone hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Fresenius Kabi USA, LLC	76045-009
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Fresenius Kabi USA, LLC	63323-852
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Fresenius Kabi USA, LLC	63323-851
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 2 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Fresenius Kabi USA, LLC	63323-853
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Fresenius Kabi USA, LLC	63323-854