DEXMEDETOMIDINE

Product NDC

57884-3091

11-digit product format

578843091

Labeler code

57884

Product ID

57884-3091_a138d0e4-4983-6782-e053-2a95a90ac30e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

DEXMEDETOMIDINE

Dosage form

INJECTION, SOLUTION, CONCENTRATE

Route

INTRAVENOUS

Labeler

Jiangsu Hengrui Medicine Co., Ltd.

Application

ANDA209065

Marketing category

ANDA

Marketing start

2017-09-19

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

2021-12-31

Current FDA listing

Historical FDA.report record