Over-the-counter drug · ANDA
Naloxone Hydrochloride NDC 51662-1659
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 |
|---|---|---|---|
| 51662-1659-2 | 51662165902 | 2 VIAL, SINGLE-DOSE in 1 CARTON (51662-1659-2) / .1 mL in 1 VIAL, SINGLE-DOSE (51662-1659-1)Marketed from Jul 30, 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 Hydrochloride
- Generic name (nonproprietary)
- naloxone hydrochloride
- Active ingredients
- Naloxone hydrochloride — 4 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Product type
- Over-the-counter 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 51662-1659_19b0603b-2420-f439-e063-6294a90ae85fSPL ID 19b0603b-2420-f439-e063-6294a90ae85fSPL set ID 19b0603b-241f-f439-e063-6294a90ae85fRxCUI 1725059UNII 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 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
N451662165902followed by a unit qualifier and the quantityPackage 51662-1659-02. 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)
• to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life
Excerpt only. Read the full label for complete information.
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 | BluePoint Laboratories | 68001-645 |
| 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 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Padagis Israel Pharmaceuticals Ltd | 45802-578 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | A-S Medication Solutions | 50090-6963 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | A-S Medication Solutions | 50090-6710 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Strategic Sourcing Services LLC | 70677-1283 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | AMERISOURCE BERGEN | 46122-812 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Proficient Rx LP | 71205-707 |
| NALOXONE HCl | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | HF Acquisition Co LLC, DBA HealthFirst | 51662-1620 |