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Buprenorphine

These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. Buprenorphine Transdermal System, CIII Initial U.S. Approval: 1981

Approved
Approval ID

2738feae-316e-426f-971c-5f142ac01b60

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 25, 2024

Manufacturers
FDA

Rhodes Pharmaceuticals L.P.

DUNS: 831928986

Products 5

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 Code42858-586
Application NumberNDA021306
Product Classification
M
Marketing Category
C73605
G
Generic Name
Buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateFebruary 28, 2023
FDA Product Classification

INGREDIENTS (4)

ethyl levulinateInactive
Code: 7BU24CSS2G
Classification: IACT
BuprenorphineActive
Quantity: 15 ug in 1 h
Code: 40D3SCR4GZ
Classification: ACTIB
oleyl oleateInactive
Code: 3X3L452Y85
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT

Buprenorphine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-493
Application NumberNDA021306
Product Classification
M
Marketing Category
C73605
G
Generic Name
Buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateFebruary 28, 2023
FDA Product Classification

INGREDIENTS (4)

BuprenorphineActive
Quantity: 10 ug in 1 h
Code: 40D3SCR4GZ
Classification: ACTIB
oleyl oleateInactive
Code: 3X3L452Y85
Classification: IACT
ethyl levulinateInactive
Code: 7BU24CSS2G
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT

Buprenorphine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-839
Application NumberNDA021306
Product Classification
M
Marketing Category
C73605
G
Generic Name
Buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateFebruary 28, 2023
FDA Product Classification

INGREDIENTS (4)

BuprenorphineActive
Quantity: 20 ug in 1 h
Code: 40D3SCR4GZ
Classification: ACTIB
ethyl levulinateInactive
Code: 7BU24CSS2G
Classification: IACT
oleyl oleateInactive
Code: 3X3L452Y85
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT

Buprenorphine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-353
Application NumberNDA021306
Product Classification
M
Marketing Category
C73605
G
Generic Name
Buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateFebruary 28, 2023
FDA Product Classification

INGREDIENTS (4)

BuprenorphineActive
Quantity: 7.5 ug in 1 h
Code: 40D3SCR4GZ
Classification: ACTIB
ethyl levulinateInactive
Code: 7BU24CSS2G
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
oleyl oleateInactive
Code: 3X3L452Y85
Classification: IACT

Buprenorphine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-750
Application NumberNDA021306
Product Classification
M
Marketing Category
C73605
G
Generic Name
Buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateFebruary 28, 2023
FDA Product Classification

INGREDIENTS (4)

ethyl levulinateInactive
Code: 7BU24CSS2G
Classification: IACT
BuprenorphineActive
Quantity: 5 ug in 1 h
Code: 40D3SCR4GZ
Classification: ACTIB
oleyl oleateInactive
Code: 3X3L452Y85
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT

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Buprenorphine - FDA Drug Approval Details