Prescription drug · NDA
Naloxone Hydrochloride Injection, USP, Auto-Injector (Naloxone hydrochloride) NDC 60842-002
Naloxone hydrochloride 10 mg/.4mL · Injection, Solution · Intramuscular, Subcutaneous · Kaleo, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60842-002-02 | 60842000202 | 10 DOSE PACK in 1 CARTON (60842-002-02) / .4 mL in 1 DOSE PACKMarketed from Feb 28, 2022 |
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)
- Naloxone Hydrochloride Injection, USP, Auto-Injector
- Generic name (nonproprietary)
- naloxone hydrochloride
- Active ingredients
- Naloxone hydrochloride — 10 mg/.4mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Subcutaneous
- Labeler
- Kaleo, Inc.NDC labeler code 60842
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215457
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 60842-002_04afe7f9-83ba-4269-a6ce-3bcc61a106d8SPL ID 04afe7f9-83ba-4269-a6ce-3bcc61a106d8SPL set ID b5463553-b775-47a3-8d10-31e01ca1ec72RxCUI 2596175UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N460842000202followed by a unit qualifier and the quantityPackage 60842-0002-02. 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)
NALOXONE HYDROCHLORIDE injection is indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. NALOXONE HYDROCHLORIDE injection is an opioid antagonist indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-pote…
Excerpt only. Read the full label for complete information.
About NDC 60842-002
- What is NDC 60842-002?
- 60842-002 is the product NDC for Naloxone Hydrochloride Injection, USP, Auto-Injector, Naloxone hydrochloride 10 mg/.4mL injection, solution, listed with the FDA by Kaleo, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naloxone Hydrochloride Injection, USP, Auto-Injector (Naloxone Hydrochloride).
- What is the active ingredient?
- Naloxone hydrochloride.
- Who is the labeler?
- Kaleo, Inc., NDC labeler code 60842. 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 Hydrochloride Injection, USP, Auto-Injector?
- 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.