Is Eton Pharmaceuticals, Inc. FDA approved?

Eton Pharmaceuticals, Inc. holds no registered establishment of its own; 14 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Eton Pharmaceuticals, Inc. make?

14 products are listed under Eton Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as capsule; granule; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Eton Pharmaceuticals, Inc.

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

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Registered sites: 0
Active NDC listings: 14
Live patents: 18
Countries: 0

Catalogue

Drug listings by form and route

14 active NDC listings: 14 human prescription drug. By marketing category: NDA 7, ANDA 6, BLA 1.

Dosage form	NDCs
capsule	4
granule	4
solution	3
injection	1
powder, for solution	1
tablet, for suspension	1

Route	NDCs
oral	13
subcutaneous	1

Labeller name on the listing	NDCs
eton pharmaceuticals, inc.	14

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8338489	HEMANGEOLpropranolol hydrochloride	use	Oct 2028
8987262	HEMANGEOLpropranolol hydrochloride	use	Oct 2028
9717740	ALKINDI SPRINKLEhydrocortisone	use	Nov 2032
9675559	ALKINDI SPRINKLEhydrocortisone	use	Jan 2033
9649280	ALKINDI SPRINKLEhydrocortisone	product	May 2034
11904046	KHINDIVIhydrocortisone	product	Feb 2043
12133914	KHINDIVIhydrocortisone	use	Feb 2043
12214010	DESMODAdesmopressin acetate	product	Apr 2044
12343372	DESMODAdesmopressin acetate	product	Apr 2044

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Alkindi Sprinkle	Hydrocortisone	granule, oral	71863-109NDA
Alkindi Sprinkle	Hydrocortisone	granule, oral	71863-110NDA
Alkindi Sprinkle	Hydrocortisone	granule, oral	71863-111NDA
Alkindi Sprinkle	Hydrocortisone	granule, oral	71863-112NDA
Betaine Anhydrous	Betaine Anhydrous	powder, for solution, oral	71863-115ANDA
Carglumic Acid	Carglumic Acid	tablet, for suspension, oral	71863-114ANDA
DESMODA	Desmopressin Acetate Oral Solution	solution, oral	71863-123NDA
HEMANGEOL	Propranolol Hydrochloride	solution, oral	71863-132NDA
Increlex	Mecasermin	injection, subcutaneous	71863-216BLA
Khindivi	Hydrocortisone	solution, oral	71863-116NDA
Nitisinone	Nitisinone	capsule, oral	71863-119ANDA
Nitisinone	Nitisinone	capsule, oral	71863-120ANDA
Nitisinone	Nitisinone	capsule, oral	71863-121ANDA
Nitisinone	Nitisinone	capsule, oral	71863-122ANDA

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Enquiry

Common questions

Is Eton Pharmaceuticals, Inc. FDA approved?: Eton Pharmaceuticals, Inc. holds no registered establishment of its own; 14 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Eton Pharmaceuticals, Inc. make?: 14 products are listed under Eton Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as capsule; granule; solution. 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.