Prescription drug · ANDA
Nalbuphine Hci NDC 51662-1420
Nalbuphine hydrochloride 10 mg/mL · Injection, Solution · Intramuscular, Intravenous, Subcutaneous · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1420-1 | 5166214200151662142001 | 1 VIAL, MULTI-DOSE in 1 CARTON (51662-1420-1) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 29, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Hci
- Generic name (nonproprietary)
- nalbuphine hci
- Active ingredients
- Nalbuphine hydrochloride — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070915
- Marketing start
- Listing expires
- Other FDA classes
- Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 51662-1420_2b37c789-d5da-dc83-e063-6294a90a4ca5SPL ID 2b37c789-d5da-dc83-e063-6294a90a4ca5SPL set ID 96139914-0708-7b58-e053-2995a90a7308RxCUI 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
N451662142001followed by a unit qualifier and the quantityPackage 51662-1420-01. 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 & 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, even at recommended doses [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 are not expected to be…
Excerpt only. Read the full label for complete information.
About NDC 51662-1420
- What is NDC 51662-1420?
- 51662-1420 is the product NDC for Nalbuphine Hci, Nalbuphine hydrochloride 10 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nalbuphine Hci.
- What is the active ingredient?
- Nalbuphine hydrochloride.
- Who is the labeler?
- HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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 Hci?
- 1 other product NDC are listed under this name. See all Nalbuphine Hci NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nalbuphine Hci products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nalbuphine Hci | Nalbuphine hydrochloride 20 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1418 | 51662-1418-01 |
Other NDCs under ANDA 070915
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 10 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Hospira, Inc. | 0409-1464 |
| Nalbuphine Hydrochloride | Nalbuphine hydrochloride 10 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | 71872-7114 |
| Nalbuphine Hydrochloride | Nalbuphine hydrochloride 10 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | ProPharma Distribution | 84549-464 |