Buprenorphine hydrochloride
Buprenorphine hydrochloride 8mg
Approved
Approval ID
7830fe02-a2ec-48cf-85ce-3e3f6dadab4e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2009
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 hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-4092
Application NumberANDA020732
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buprenorphine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2009
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT