Prescription drug · NDA
Rextovy (Naloxone hydrochloride) NDC 76329-3669
Naloxone hydrochloride 4 mg/.25mL · Spray · Nasal · International Medication Systems, Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76329-3669-2 | 76329366902 | 2 CONTAINER in 1 CONTAINER (76329-3669-2) / .25 mL in 1 CONTAINERMarketed from May 7, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Rextovy
- Generic name (nonproprietary)
- naloxone hydrochloride
- Active ingredients
- Naloxone hydrochloride — 4 mg/.25mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- International Medication Systems, Ltd.NDC labeler code 76329
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208969
- Marketing start
- Marketing end
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 76329-3669_3bfbdfba-2f14-4e34-9abc-6555d4a3d093SPL ID 3bfbdfba-2f14-4e34-9abc-6555d4a3d093
- 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
N476329366902followed by a unit qualifier and the quantityPackage 76329-3669-02. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 76329-3669
- What is NDC 76329-3669?
- 76329-3669 is the product NDC for Rextovy (naloxone hydrochloride), Naloxone hydrochloride 4 mg/.25mL spray, listed with the FDA by International Medication Systems, Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rextovy (Naloxone Hydrochloride).
- What is the active ingredient?
- Naloxone hydrochloride.
- Who is the labeler?
- International Medication Systems, Ltd., NDC labeler code 76329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rextovy?
- 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.