NDC codes

FDA NDC Directory
Product NDC (as listed)12496-0003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width12496-0003Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
12496-0003-2124960003022 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

N412496000302 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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