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SUBSYS

These highlights do not include all the information needed to use SUBSYS safely and effectively. See full prescribing information for SUBSYS. SUBSYS®(fentanyl sublingual spray), CII Initial U.S. Approval: 1968

Approved
Approval ID

be7670d5-b88a-13bd-e053-2995a90a2f78

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 28, 2021

Manufacturers
FDA

West Therapeutics Development, LLC

DUNS: 080707245

Products 7

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71500-016
Application NumberNDA202788
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateApril 28, 2021
FDA Product Classification

INGREDIENTS (1)

FENTANYLActive
Quantity: 0.8 mg in 1 1
Code: UF599785JZ
Classification: ACTIB

fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71500-006
Application NumberNDA202788
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateApril 28, 2021
FDA Product Classification

INGREDIENTS (1)

FENTANYLActive
Quantity: 0.6 mg in 1 1
Code: UF599785JZ
Classification: ACTIB

fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71500-001
Application NumberNDA202788
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateApril 28, 2021
FDA Product Classification

INGREDIENTS (1)

FENTANYLActive
Quantity: 0.1 mg in 1 1
Code: UF599785JZ
Classification: ACTIB

fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71500-004
Application NumberNDA202788
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateApril 28, 2021
FDA Product Classification

INGREDIENTS (1)

FENTANYLActive
Quantity: 0.4 mg in 1 1
Code: UF599785JZ
Classification: ACTIB

fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71500-008
Application NumberNDA202788
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateApril 28, 2021
FDA Product Classification

INGREDIENTS (1)

FENTANYLActive
Quantity: 0.8 mg in 1 1
Code: UF599785JZ
Classification: ACTIB

fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71500-012
Application NumberNDA202788
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateApril 28, 2021
FDA Product Classification

INGREDIENTS (1)

FENTANYLActive
Quantity: 0.6 mg in 1 1
Code: UF599785JZ
Classification: ACTIB

fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71500-002
Application NumberNDA202788
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateApril 28, 2021
FDA Product Classification

INGREDIENTS (1)

FENTANYLActive
Quantity: 0.2 mg in 1 1
Code: UF599785JZ
Classification: ACTIB

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SUBSYS - FDA Drug Approval Details