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
NDC Product Code54868-5750
Application NumberNDA020733
Marketing CategoryC73594
Route of AdministrationSUBLINGUAL
Effective DateJuly 27, 2010
Generic Namebuprenorphine hydrochloride and naloxone hydrochloride
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
NDC Product Code54868-5707
Application NumberNDA020733
Marketing CategoryC73594
Route of AdministrationSUBLINGUAL
Effective DateJuly 27, 2010
Generic Namebuprenorphine hydrochloride and naloxone hydrochloride
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