Buprenorphine

Product NDC

70518-0711

11-digit product format

705180711

Labeler code

70518

Product ID

70518-0711_a0f5c3ef-70c2-6449-e053-2a95a90a91b8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Buprenorphine

Dosage form

TABLET

Route

SUBLINGUAL

Labeler

REMEDYREPACK INC.

Application

ANDA201760

Marketing category

ANDA

Marketing start

2017-08-24

Marketing end

0000-00-00

Substance

BUPRENORPHINE HYDROCHLORIDE

Active strength

2 mg/1

Pharmacologic classes

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

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record