Over-the-counter drug · NDA
Narcan (naloxone hydrochloride nasal) NDC 69547-627
Naloxone hydrochloride 4 mg/.1mL · Spray · Nasal · Emergent Devices Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69547-627-02 | 69547062702 | 2 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-02) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 28, 2023 | |
| 69547-627-05 | 69547062705 | 1 CASE in 1 CARTON (69547-627-05) / 2 VIAL, SINGLE-DOSE in 1 CASE / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2026 | |
| 69547-627-06 | 69547062706 | 6 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-06) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2026 | |
| 69547-627-24 | 69547062724 | 24 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-24) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Narcan
- Generic name (nonproprietary)
- naloxone hydrochloride nasal
- Active ingredients
- Naloxone hydrochloride — 4 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Emergent Devices Inc.
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208411
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 69547-627_5943126a-0a41-d369-e063-6294a90ac238SPL ID 5943126a-0a41-d369-e063-6294a90ac238SPL set ID a0ebc83d-2892-40de-bc0a-775ce90b30dbRxCUI 1725059, 1725064UNII 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
N469547062702followed by a unit qualifier and the quantityPackage 69547-0627-02. 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)
Uses 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 NDA 208411
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 |
|---|---|---|---|---|
| Narcannaloxone hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Emergent Devices Inc. | 69547-353 |
| Naloxone Hydrochloridenaloxone hydrochloride nasal | Naloxone hydrochloride 4 mg/.1mL | InhalantNasal | A-S Medication Solutions | 50090-5908 |
| Narcan Naloxone Hci | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | HF Acquisition Co LLC, DBA HealthFirst | 51662-1240 |
| Narcannaloxone hydrochloride nasal | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Sportpharm LLC | 85766-076 |
| Narcan Naloxone HCL | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | HF Acquisition Co LLC, DBA HealthFirst | 51662-1642 |
| Narcannaloxone hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | A-S Medication Solutions | 50090-2422 |
| Narcannaloxone hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Proficient Rx LP | 71205-528 |