Prescription drug · NDA
Opvee (Nalmefene hydrochloride) NDC 12496-0003
Nalmefene hydrochloride 2.7 mg/100uL · Spray · Nasal · Indivior Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 12496-0003-2 | 12496000302 | 2 BLISTER PACK in 1 CARTON (12496-0003-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (12496-0003-1) / 100 uL in 1 VIAL, SINGLE-DOSEMarketed from Oct 2, 2023 |
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)
- Opvee
- Generic name (nonproprietary)
- nalmefene hydrochloride
- Active ingredients
- Nalmefene hydrochloride — 2.7 mg/100uL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Indivior Inc.NDC labeler code 12496
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217470
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 12496-0003_47e34536-62c2-9ceb-e063-6294a90a57beSPL ID 47e34536-62c2-9ceb-e063-6294a90a57beSPL set ID 999a4269-9e54-4801-b2ac-2a7276f0b94fRxCUI 2639721, 2639727UNII K7K69QC05X
- 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
N412496000302followed by a unit qualifier and the quantityPackage 12496-0003-02. 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)
OPVEE nasal spray is indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. OPVEE nasal spray is not a substitute for emergency medical care. OPVEE nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central …
Excerpt only. Read the full label for complete information.
About NDC 12496-0003
- What is NDC 12496-0003?
- 12496-0003 is the product NDC for Opvee (nalmefene hydrochloride), Nalmefene hydrochloride 2.7 mg/100uL spray, listed with the FDA by Indivior Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Opvee (Nalmefene hydrochloride).
- What is the active ingredient?
- Nalmefene hydrochloride.
- Who is the labeler?
- Indivior Inc., NDC labeler code 12496. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Opvee?
- 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.