Marcaine

Product NDC

31382-557

11-digit product format

313820557

Labeler code

31382

Product ID

31382-557_de328af3-2345-40cd-a393-ab91adc5c9a8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

bupivacaine hydrochloride and epinephrine bitartrate

Dosage form

INJECTION, SOLUTION

Route

SUBCUTANEOUS

Labeler

Carestream Health Inc.

Application

ANDA077250

Marketing category

ANDA

Marketing start

2013-06-01

Marketing end

0000-00-00

Substance

BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE

Active strength

5 mg/mL; mg/mL

Pharmacologic classes

Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record