Prescription drug · NDA
Kloxxado (Naloxone hcl) NDC 59467-679
Naloxone hydrochloride 8 mg/.1mL · Spray · Nasal · Hikma Specialty USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59467-679-01 | 59467067901 | .1 mL in 1 VIAL, SINGLE-DOSE (59467-679-01)Marketed from Aug 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)
- Kloxxado
- Generic name (nonproprietary)
- naloxone hcl
- Active ingredients
- Naloxone hydrochloride — 8 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Hikma Specialty USA Inc.NDC labeler code 59467
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212045
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 59467-679_da424329-9a63-4df3-bced-4157d2086e20SPL ID da424329-9a63-4df3-bced-4157d2086e20SPL set ID ebf0f833-c1c0-487c-8f29-01fa8c61b6cbRxCUI 2540703, 2540709UNII F850569PQRUPC 0359467679015
- 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
N459467067901followed by a unit qualifier and the quantityPackage 59467-0679-01. 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)
KLOXXADO is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. KLOXXADO is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO is not a substitute for emergency medical care. KLOXXADO 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, for adult and pediatric patients. (1) KLOXXADO is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOX…
Excerpt only. Read the full label for complete information.
About NDC 59467-679
- What is NDC 59467-679?
- 59467-679 is the product NDC for Kloxxado (naloxone hcl), Naloxone hydrochloride 8 mg/.1mL spray, listed with the FDA by Hikma Specialty USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kloxxado (Naloxone HCL).
- What is the active ingredient?
- Naloxone hydrochloride.
- Who is the labeler?
- Hikma Specialty USA Inc., NDC labeler code 59467. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kloxxado?
- 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.