SUBLOCADE
These highlights do not include all the information needed to use SUBLOCADE safely and effectively. See full prescribing information for SUBLOCADE. SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use, CIII Initial U.S. Approval: 2002
Approved
Approval ID
6189fb21-9432-45f8-8481-0bfaf3ccde95
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Indivior Inc.
DUNS: 797408549
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
buprenorphine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12496-0100
Application NumberNDA209819
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 25, 2022
FDA Product Classification
INGREDIENTS (3)
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 15000 MW)Inactive
Code: C329FPO0UC
Classification: IACT
MethylpyrrolidoneInactive
Code: JR9CE63FPM
Classification: IACT
buprenorphineActive
Quantity: 100 mg in 1 1
Code: 40D3SCR4GZ
Classification: ACTIB
buprenorphine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12496-0300
Application NumberNDA209819
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 25, 2022
FDA Product Classification
INGREDIENTS (3)
buprenorphineActive
Quantity: 300 mg in 1 1
Code: 40D3SCR4GZ
Classification: ACTIB
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 15000 MW)Inactive
Code: C329FPO0UC
Classification: IACT
MethylpyrrolidoneInactive
Code: JR9CE63FPM
Classification: IACT