buprenorphine hydrochloride

Product NDC

35356-556

11-digit product format

353560556

Labeler code

35356

Product ID

35356-556_c8c73f4a-6e3f-425c-8806-0ed1c9c2e59a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

buprenorphine hydrochloride

Dosage form

TABLET

Route

SUBLINGUAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA090622

Marketing category

ANDA

Marketing start

2010-09-24

Marketing end

0000-00-00

Substance

BUPRENORPHINE HYDROCHLORIDE

Active strength

8 mg/1

Pharmacologic classes

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

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record