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Butrans

These highlights do not include all the information needed to use BUTRANS safely and effectively. See full prescribing information for BUTRANS. BUTRANS (buprenorphine) transdermal system, CIIIInitial U.S. Approval: 1981

Approved
Approval ID

794aa355-66de-41b8-aedf-f2c40f6bc664

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 18, 2023

Manufacturers
FDA

Purdue Pharma LP

DUNS: 932323652

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 Code59011-751
Application NumberNDA021306
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 23, 2022
FDA Product Classification

INGREDIENTS (4)

buprenorphineActive
Quantity: 10 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 Code59011-750
Application NumberNDA021306
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 23, 2022
FDA Product Classification

INGREDIENTS (4)

buprenorphineActive
Quantity: 5 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 Code59011-757
Application NumberNDA021306
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 23, 2022
FDA Product Classification

INGREDIENTS (4)

ETHYL LEVULINATEInactive
Code: 7BU24CSS2G
Classification: IACT
buprenorphineActive
Quantity: 7.5 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 Code59011-758
Application NumberNDA021306
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 23, 2022
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 Code59011-752
Application NumberNDA021306
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 23, 2022
FDA Product Classification

INGREDIENTS (4)

POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
OLEYL OLEATEInactive
Code: 3X3L452Y85
Classification: IACT
buprenorphineActive
Quantity: 20 ug in 1 h
Code: 40D3SCR4GZ
Classification: ACTIB
ETHYL LEVULINATEInactive
Code: 7BU24CSS2G
Classification: IACT

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