What is NDC 0404-9918?

0404-9918 is the product NDC for Nalbuphine Hydrochloride, Nalbuphine hydrochloride 10 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nalbuphine Hydrochloride?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nalbuphine Hydrochloride NDC 0404-9918

NDC codes

FDA NDC Directory

Product NDC (as listed)0404-9918Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00404-9918Add 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
0404-9918-01	00404991801	1 AMPULE in 1 BAG (0404-9918-01) / 1 mL in 1 AMPULEMarketed from Jan 13, 2022

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): Nalbuphine Hydrochloride
Generic name (nonproprietary): nalbuphine hydrochloride
Active ingredients: Nalbuphine hydrochloride — 10 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Henry Schein, Inc.NDC labeler code 0404
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070914
Marketing start: Jan 13, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 0404-9918_0e0e0bdd-27ee-48e6-9390-56ec6e71ecccSPL ID 0e0e0bdd-27ee-48e6-9390-56ec6e71ecccSPL set ID 596826ff-e471-4d4f-9a73-2a34e2af2dd6RxCUI 1866543UNII ZU4275277R
Pharmacologic class: Opioid Agonist/Antagonist

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

N400404991801 followed by a unit qualifier and the quantity

Package 00404-9918-01. 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 May 21, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ], reserve Nalbuphine Hydrochloride Injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): •Have not been tolerated, or ar…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0404-9918

What is NDC 0404-9918?: 0404-9918 is the product NDC for Nalbuphine Hydrochloride, Nalbuphine hydrochloride 10 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nalbuphine Hydrochloride.
What is the active ingredient?: Nalbuphine hydrochloride.
Who is the labeler?: Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nalbuphine Hydrochloride?: 15 other product NDCs are listed under this name. See all Nalbuphine 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 Nalbuphine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nalbuphine Hydrochloride	Nalbuphine hydrochloride 10 mg/mL	InjectionIntramuscular, Intravenous, Subconjunctival	Henry Schein, Inc.	0404-9767	00404-9767-10
Nalbuphine Hydrochloride	Nalbuphine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Henry Schein, Inc.	0404-9766	00404-9766-10
Nalbuphine hydrochloride	Nalbuphine hydrochloride 10 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Medical Purchasing Solutions, LLC	71872-7331	71872-7331-01
Nalbuphine hydrochloride	Nalbuphine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Somerset Therapeutics, LLC	70069-662	70069-0662-10
Nalbuphine hydrochloride	Nalbuphine hydrochloride 10 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Somerset Therapeutics, LLC	70069-661	70069-0661-10
Nalbuphine hydrochloride	Nalbuphine hydrochloride 10 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Somerset Therapeutics, LLC	70069-671	70069-0671-10
Nalbuphine hydrochloride	Nalbuphine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Somerset Therapeutics, LLC	70069-672	70069-0672-10
Nalbuphine Hydrochloride	Nalbuphine hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hospira, Inc.	0409-1463	00409-1463-49
Nalbuphine Hydrochloride	Nalbuphine hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hospira, Inc.	0409-1464	00409-1464-01
Nalbuphine Hydrochloride	Nalbuphine hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Medical Purchasing Solutions, LLC	71872-7114	71872-7114-01

All 16 Nalbuphine Hydrochloride NDCs

Other NDCs under ANDA 070914

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

FDA NDC Directory listings under ANDA 070914
Product	Strength	Form · route	Labeler	Product NDC
Nalbuphine Hydrochloride	Nalbuphine hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hospira, Inc.	0409-1463
Nalbuphine Hydrochloride	Nalbuphine hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Hospira, Inc.	0409-1463