Dexmedetomidine Hydrochloride

Product NDC

45963-906

11-digit product format

459630906

Labeler code

45963

Product ID

45963-906_30914264-8e2e-4f02-bb08-4b7dd1ead7ae

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dexmedetomidine Hydrochloride

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Actavis Pharma, Inc.

Application

ANDA204686

Marketing category

ANDA

Marketing start

2017-01-13

Marketing end

0000-00-00

Substance

DEXMEDETOMIDINE HYDROCHLORIDE

Active strength

100 ug/mL

Pharmacologic classes

Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record