ASENAPINE
These highlights do not include all the information needed to use ASENAPINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for ASENAPINE SUBLINGUAL TABLETS. ASENAPINE sublingual tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
3512687b-d1c7-45c4-8822-3a2ad53575a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Sigmapharm Laboratories, LLC
DUNS: 556234636
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ASENAPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-017
Application NumberANDA206107
Product Classification
M
Marketing Category
C73584
G
Generic Name
ASENAPINE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (13)
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
ASENAPINEActive
Quantity: 10 mg in 1 1
Code: JKZ19V908O
Classification: ACTIB
ASENAPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-016
Application NumberANDA206107
Product Classification
M
Marketing Category
C73584
G
Generic Name
ASENAPINE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (13)
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
ASENAPINEActive
Quantity: 5 mg in 1 1
Code: JKZ19V908O
Classification: ACTIB