buprenorphine hydrochloride

Product NDC

70518-0442

11-digit product format

705180442

Labeler code

70518

Product ID

70518-0442_851a3706-cc9c-b3f8-e053-2a91aa0ac0f5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

buprenorphine hydrochloride

Dosage form

TABLET

Route

SUBLINGUAL

Labeler

REMEDYREPACK INC.

Application

ANDA090622

Marketing category

ANDA

Marketing start

2017-04-20

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