BUPRENORPHINE

Product NDC

70518-2218

11-digit product format

705182218

Labeler code

70518

Product ID

70518-2218_9738a2f0-7f16-ea4e-e053-2a95a90abbfb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

BUPRENORPHINE

Dosage form

TABLET

Route

SUBLINGUAL

Labeler

REMEDYREPACK INC.

Application

ANDA207276

Marketing category

ANDA

Marketing start

2019-07-15

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