Prescription drug · NDA
Narcan (Naloxone hydrochloride) NDC 69547-353
Naloxone hydrochloride 4 mg/.1mL · Spray · Nasal · Emergent Devices Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Narcan
- Generic name (nonproprietary)
- naloxone hydrochloride
- Active ingredients
- Naloxone hydrochloride — 4 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Emergent Devices Inc.NDC labeler code 69547
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208411
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 69547-353_4536fef4-e317-a7fd-e063-6294a90aa0e3SPL ID 4536fef4-e317-a7fd-e063-6294a90aa0e3SPL set ID 724df050-5332-4d0a-9a5f-17bf08a547e1RxCUI 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
NARCAN Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN Nasal Spray is not a substitute for emergency medical care. NARCAN Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ( 1 ) NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. ( 1 ) NARCAN Nasal S…
Excerpt only. Read the full label for complete information.
About NDC 69547-353
- What is NDC 69547-353?
- 69547-353 is the product NDC for Narcan (naloxone hydrochloride), Naloxone hydrochloride 4 mg/.1mL spray, listed with the FDA by Emergent Devices Inc..
- What drug is associated with this NDC?
- Narcan (Naloxone Hydrochloride).
- What is the active ingredient?
- Naloxone hydrochloride.
- Who is the labeler?
- Emergent Devices Inc., NDC labeler code 69547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Narcan?
- 4 other product NDCs are listed under this name. See all Narcan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Narcan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Narcannaloxone hydrochloride nasal | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Emergent Devices Inc. | 69547-627 | 69547-0627-0269547-0627-0569547-0627-06+1 more |
| Narcannaloxone hydrochloride nasal | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Sportpharm LLC | 85766-076 | 85766-0076-02 |
| Narcannaloxone hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | A-S Medication Solutions | 50090-2422 | 50090-2422-00 |
| Narcannaloxone hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Proficient Rx LP | 71205-528 | 71205-0528-02 |
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 |
|---|---|---|---|---|
| Naloxone Hydrochloridenaloxone hydrochloride nasal | Naloxone hydrochloride 4 mg/.1mL | InhalantNasal | A-S Medication Solutions | 50090-5908 |
| Narcannaloxone hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | A-S Medication Solutions | 50090-2422 |
| Narcannaloxone hydrochloride nasal | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Emergent Devices Inc. | 69547-627 |
| Narcannaloxone hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Proficient Rx LP | 71205-528 |
| Narcannaloxone hydrochloride nasal | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Sportpharm LLC | 85766-076 |
| Narcan Naloxone Hci | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | HF Acquisition Co LLC, DBA HealthFirst | 51662-1240 |
| Narcan Naloxone HCL | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | HF Acquisition Co LLC, DBA HealthFirst | 51662-1642 |