Buprenorphine HCl
These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIIIInitial U.S. Approval: 1981
Approved
Approval ID
d5a8c41e-413e-4d48-9739-d158e5681dd0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2022
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Buprenorphine HCl
PRODUCT DETAILS
NDC Product Code71335-1163
Application NumberANDA078633
Marketing CategoryC73584
Route of AdministrationSUBLINGUAL
Effective DateMarch 28, 2022
Generic NameBuprenorphine HCl
INGREDIENTS (10)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT