Buprenorphine Hydrochloride Sublingual

Product NDC
70518-0652
11-digit product format
705180652
Labeler code
70518
Product ID
70518-0652_7faed134-216b-7c41-e053-2a91aa0a1dfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride sublingual
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
REMEDYREPACK INC.
Application
ANDA201066
Marketing category
ANDA
Marketing start
2017-07-31
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