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Dexmedetomidine Hydrochloride Injection

Somerset Therapeutics, LLC · Available

Current70069-759-04Anesthesia
Open FDA's page for this record
Update type
Reverified
Initial posting date
04/10/2020
Package NDC
70069-759-04
Generic name
Dexmedetomidine Hydrochloride Injection
Contact info
732-554-1037
Availability
Available
Update date
09/11/2026
Dosage form
Injection
Presentation
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04)
Company name
Somerset Therapeutics, LLC
Status
Current
Therapeutic category
Anesthesia
Harmonized identifiers (openFDA)
Application number
ANDA218112
Brand name
DEXMEDETOMIDINE HYDROCHLORIDE
Generic name
DEXMEDETOMIDINE HYDROCHLORIDE
Manufacturer name
Somerset Therapeutics, LLC
Product NDC
70069-759, 70069-758
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
DEXMEDETOMIDINE HYDROCHLORIDE
RxCUI
1788947
SPL ID
6a1a2c33-1467-4eb0-adc6-6e21771fbf6b
SPL set ID
649e777b-9b30-4f1e-9fb9-6bba57580976
Package NDC
70069-758-04, 70069-759-04
UNII
1018WH7F9I
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.