buprenorphine hydrochloride

Product NDC
70518-2216
11-digit product format
705182216
Labeler code
70518
Product ID
70518-2216_8e3b7aa2-cde0-fb45-e053-2a95a90a5c76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
REMEDYREPACK INC.
Application
ANDA090622
Marketing category
ANDA
Marketing start
2019-07-15
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
2020-12-31
Current FDA listing
Historical FDA.report record