Prescription drug · ANDA
Nalbuphine Hydrochloride NDC 0404-9767
Nalbuphine hydrochloride 10 mg/mL · Injection · Intramuscular, Intravenous, Subconjunctival · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9767-10 | 00404976710 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9767-10) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 11, 2025 |
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
- Route
- Intramuscular, Intravenous, Subconjunctival
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216049
- Marketing start
- Listing expires
- Other FDA classes
- Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0404-9767_c5a5987e-4bb8-4ff2-b111-0b62911ca8e4SPL ID c5a5987e-4bb8-4ff2-b111-0b62911ca8e4SPL set ID 4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2dRxCUI 904415UNII 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.
- NDC on a medical claim
N400404976710followed by a unit qualifier and the quantityPackage 00404-9767-10. 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 . 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.
Other NDCs under ANDA 216049
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nalbuphine Hydrochloride | Nalbuphine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Henry Schein, Inc. | 0404-9766 |
| Nalbuphine hydrochloride | Nalbuphine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Somerset Therapeutics, LLC | 70069-662 |
| Nalbuphine hydrochloride | Nalbuphine hydrochloride 10 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Somerset Therapeutics, LLC | 70069-661 |
| Nalbuphine hydrochloride | Nalbuphine hydrochloride 10 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | 71872-7331 |