Suboxone
Approved
Approval ID
97677ce7-9562-43d0-8b99-8d1f37c1e3c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
buprenorphine hydrochloride and naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5750
Application NumberNDA020733
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine hydrochloride and naloxone hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJuly 27, 2010
FDA Product Classification
INGREDIENTS (10)
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIB
NALOXONE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: F850569PQR
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
buprenorphine hydrochloride and naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5707
Application NumberNDA020733
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine hydrochloride and naloxone hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJuly 27, 2010
FDA Product Classification
INGREDIENTS (10)
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
NALOXONE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: F850569PQR
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT