Suboxone

Product NDC

55700-147

11-digit product format

557000147

Labeler code

55700

Product ID

55700-147_5569aed9-127a-4932-9e20-8b9351791f6d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

buprenorphine hydrochloride, naloxone hydrochloride

Dosage form

FILM, SOLUBLE

Route

SUBLINGUAL

Labeler

Quality Care Products, LLC

Application

NDA022410

Marketing category

NDA

Marketing start

2010-09-13

Marketing end

0000-00-00

Substance

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Active strength

8 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

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record