Prescription drug · ANDA
NALOXONE HCl NDC 51662-1620
Naloxone hydrochloride 4 mg/.1mL · Spray · Nasal · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1620-1 | 5166216200151662162001 | .1 mL in 1 VIAL, SINGLE-DOSE (51662-1620-1)Marketed from Apr 10, 2023 | |
| 51662-1620-2 | 5166216200251662162002 | 2 VIAL, SINGLE-DOSE in 1 CARTON (51662-1620-2) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 10, 2023 |
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 HCl
- Generic name (nonproprietary)
- naloxone hcl
- Active ingredients
- Naloxone hydrochloride — 4 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211951
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 51662-1620_100bc933-5bf3-8de2-e063-6294a90a7ba6SPL ID 100bc933-5bf3-8de2-e063-6294a90a7ba6SPL set ID f8fcda15-8ba6-e66a-e053-6294a90a385cRxCUI 1725059UNII F850569PQRUPC 0345802811004
- 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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N451662162001followed by a unit qualifier and the quantityPackage 51662-1620-01. 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 HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Naloxone HCl Nasal Spray is not a substitute for emergency medical care. Limitations of Use: Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.
Excerpt only. Read the full label for complete information.
About NDC 51662-1620
- What is NDC 51662-1620?
- 51662-1620 is the product NDC for NALOXONE HCl, Naloxone hydrochloride 4 mg/.1mL spray, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- NALOXONE HCl.
- What is the active ingredient?
- Naloxone 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 NALOXONE HCl?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 211951
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/.1mL | SprayNasal | Padagis Israel Pharmaceuticals Ltd | 45802-578 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | AMERISOURCE BERGEN | 46122-812 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | A-S Medication Solutions | 50090-6710 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | A-S Medication Solutions | 50090-6963 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | HF Acquisition Co LLC, DBA HealthFirst | 51662-1659 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | BluePoint Laboratories | 68001-645 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Strategic Sourcing Services LLC | 70677-1283 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Proficient Rx LP | 71205-707 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Bryant Ranch Prepack | 72162-2376 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Advanced Rx of Tennessee, LLC | 80425-0409 |