Buprenorphine HCl

Product NDC

55700-303

11-digit product format

557000303

Labeler code

55700

Product ID

55700-303_35a07151-53db-4ce1-99d4-d1cfd73f5132

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Buprenorphine HCl

Dosage form

TABLET

Route

SUBLINGUAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA078633

Marketing category

ANDA

Marketing start

2009-10-08

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

2020-12-31

Current FDA listing

Historical FDA.report record