Prescription drug · NDA
Narcan (Naloxone hydrochloride) NDC 71205-528
Naloxone hydrochloride 4 mg/.1mL · Spray · Nasal · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-528-02 | 7120505280271205052802 | 2 VIAL, SINGLE-DOSE in 1 PACKAGE (71205-528-02) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 3, 2021 |
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
- Active ingredients
- Naloxone hydrochloride — 4 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Proficient Rx LPNDC labeler code 71205
- 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 71205-528_9f01f1ed-3bba-4243-8306-114d90da372bSPL ID 9f01f1ed-3bba-4243-8306-114d90da372bSPL set ID 76b5a1ce-e601-457c-ab35-43533bba4394RxCUI 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
N471205052802followed by a unit qualifier and the quantityPackage 71205-0528-02. 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)
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 71205-528
- What is NDC 71205-528?
- 71205-528 is the product NDC for Narcan (naloxone hydrochloride), Naloxone hydrochloride 4 mg/.1mL spray, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Narcan (Naloxone Hydrochloride).
- What is the active ingredient?
- Naloxone hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. 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 | Emergent Devices Inc. | 69547-353 | — |
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 | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Emergent Devices Inc. | 69547-353 |
| Narcannaloxone hydrochloride nasal | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Emergent Devices Inc. | 69547-627 |
| 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 |