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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

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SUBLOCADE - FDA Drug Approval Details