Prescription drug · ANDA
Nalbuphine Hydrochloride NDC 0409-1467
Nalbuphine hydrochloride 20 mg/mL · Injection, Solution · Intramuscular, Intravenous, Subcutaneous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-1467-01 | 00409146701 | 25 CARTON in 1 CASE (0409-1467-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1467-61) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from May 16, 2005 |
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 — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070918
- Marketing start
- Listing expires
- Other FDA classes
- Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0409-1467_cbcbf107-67c0-4a8a-a25d-5a05c43a0bfdSPL ID cbcbf107-67c0-4a8a-a25d-5a05c43a0bfdSPL set ID 6025e8d4-5083-4c3a-58a0-050e7b0b6150RxCUI 904415, 904440, 1866543, 1866551UNII 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
N400409146701followed by a unit qualifier and the quantityPackage 00409-1467-01. 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 . 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ], reserve opioid analgesics, including Nalbuphine Hydrochloride Injection, for use in patients for whom alternative treatme…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070918
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 | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | 71872-7320 |
| Nalbuphine Hci | Nalbuphine hydrochloride 20 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1418 |