Prescription drug · ANDA
Naloxone Hydrochloride NDC 51662-1673
Naloxone hydrochloride .4 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 |
|---|---|---|---|
| 51662-1673-1 | 51662167301 | 10 mL in 1 VIAL, GLASS (51662-1673-1)Marketed from Jul 26, 2017 |
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)
- Naloxone Hydrochloride
- Generic name (nonproprietary)
- naloxone hydrochloride
- Active ingredients
- Naloxone hydrochloride — .4 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207634
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 51662-1673_4d66b96a-acbc-2292-e063-6294a90af788SPL ID 4d66b96a-acbc-2292-e063-6294a90af788SPL set ID 4d66b96a-acbb-2292-e063-6294a90af788RxCUI 1191222UNII F850569PQR
- Pharmacologic class
- Opioid 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
N451662167301followed by a unit qualifier and the quantityPackage 51662-1673-01. 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 .
Indications (excerpt from the label)
Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207634
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 |
|---|---|---|---|---|
| Naloxone Hydrochloride | Naloxone hydrochloride .4 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Somerset Therapeutics, LLC | 70069-072 |
| Naloxone Hydrochloride | Naloxone hydrochloride .4 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1426 |
| Naloxone Hydrochloride | Naloxone hydrochloride .4 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | ProPharma Distribution | 84549-072 |
| Naloxone Hydrochloride | Naloxone hydrochloride .4 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | 71872-7326 |