buprenorphine hydrochloride
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 CIII Initial U.S. Approval: 2002
Approved
Approval ID
a891f3ff-5cad-4e92-b4c4-d5108c8df550
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Akorn Operating Company LLC (dba Akorn)
DUNS: 117696873
Products 2
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 Code50383-924
Application NumberANDA090622
Product Classification
M
Marketing Category
C73584
G
Generic Name
buprenorphine hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (8)
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
STARCH, CORNInactive
Quantity: 39.88 mg in 1 1
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
buprenorphine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-930
Application NumberANDA090622
Product Classification
M
Marketing Category
C73584
G
Generic Name
buprenorphine hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (8)
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Quantity: 37.79 mg in 1 1
Code: O8232NY3SJ
Classification: IACT
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT