Suboxone

Product NDC

63629-4028

11-digit product format

636294028

Labeler code

63629

Product ID

63629-4028_897164c4-714d-4b8a-8b6a-9ffc7f3627a0

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

buprenorphine and naloxone

Dosage form

FILM, SOLUBLE

Route

SUBLINGUAL

Labeler

Bryant Ranch Prepack

Application

NDA022410

Marketing category

NDA

Marketing start

2010-09-13

Marketing end

0000-00-00

Substance

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Active strength

2 mg/1; mg/1

Pharmacologic classes

Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]

DEA schedule

CIII

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record