Dexmedetomidine Hydrochloride

Product NDC

0781-3297

11-digit product format

007813297

Labeler code

0781

Product ID

0781-3297_9772c1f9-9659-407b-b22d-fa40d41429eb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dexmedetomidine Hydrochloride

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Sandoz Inc

Application

ANDA091465

Marketing category

ANDA

Marketing start

2016-11-14

Marketing end

2020-12-31

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

0000-00-00

Current FDA listing

Historical FDA.report record