Is Neurelis, Inc FDA approved?

Neurelis, Inc holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Neurelis, Inc make?

4 products are listed under Neurelis, Inc in the openFDA NDC Directory, most often as spray. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Neurelis, Inc

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 4
Live patents: 24
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
spray	4

Route	NDCs
nasal	4

Labeller name on the listing	NDCs
neurelis, inc	4

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11241414	VALTOCOdiazepam	product	Mar 2029
11793786	VALTOCOdiazepam	product	Mar 2029
12268664	VALTOCOdiazepam	product	Mar 2029
12521400	VALTOCOdiazepam	product	Mar 2029
8895546	VALTOCOdiazepam	product	Mar 2029
12337061	VALTOCOdiazepam	use	Jun 2032
12324852	VALTOCOdiazepam	use	Oct 2032
12599611	VALTOCOdiazepam	use	Jun 2042

Product	Exclusivity	Until
VALTOCODIAZEPAM	NPP New patient population	Apr 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Valtoco	diazepam	spray, nasal	72252-505NDA
Valtoco	diazepam	spray, nasal	72252-510NDA
Valtoco	diazepam	spray, nasal	72252-515NDA
Valtoco	diazepam	spray, nasal	72252-520NDA

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Enquiry

Common questions

Is Neurelis, Inc FDA approved?: Neurelis, Inc holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Neurelis, Inc make?: 4 products are listed under Neurelis, Inc in the openFDA NDC Directory, most often as spray. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.