Buprenorphine Sublingual

Product NDC
72189-579
11-digit product format
721890579
Labeler code
72189
Product ID
72189-579_2204e135-6a0d-68a2-e063-6394a90ac019
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine Sublingual
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Direct_rx
Application
ANDA201760
Marketing category
ANDA
Marketing start
2024-09-13
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
56W8MW3EN1BUPRENORPHINE HYDROCHLORIDE53152-21-9BUPRENORPHINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-579-607218905796060 TABLET in 1 BOTTLE (72189-579-60) 60 tablet2024-09-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buprenorphine Sublingual C-lllDirect_rx2024-09-13HUMAN PRESCRIPTION DRUG LABEL1