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 Initial U.S. Approval: 2009
Approved
Approval ID
4c7a1b17-e73e-4417-a172-bfb03569d7ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 26, 2021
Manufacturers
FDA
MSN LABORATORIES PRIVATE LIMITED
DUNS: 650786952
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ASENAPINE MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69539-245
Application NumberANDA205960
Product Classification
M
Marketing Category
C73584
G
Generic Name
ASENAPINE MALEATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateAugust 26, 2021
FDA Product Classification
INGREDIENTS (8)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ASENAPINE MALEATEActive
Quantity: 2.5 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ASENAPINE MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69539-060
Application NumberANDA205960
Product Classification
M
Marketing Category
C73584
G
Generic Name
ASENAPINE MALEATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateAugust 26, 2021
FDA Product Classification
INGREDIENTS (8)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ASENAPINE MALEATEActive
Quantity: 10 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
ASENAPINE MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69539-059
Application NumberANDA205960
Product Classification
M
Marketing Category
C73584
G
Generic Name
ASENAPINE MALEATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateAugust 26, 2021
FDA Product Classification
INGREDIENTS (8)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ASENAPINE MALEATEActive
Quantity: 10 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ASENAPINE MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69539-058
Application NumberANDA205960
Product Classification
M
Marketing Category
C73584
G
Generic Name
ASENAPINE MALEATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateAugust 26, 2021
FDA Product Classification
INGREDIENTS (8)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ASENAPINE MALEATEActive
Quantity: 5 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ASENAPINE MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69539-057
Application NumberANDA205960
Product Classification
M
Marketing Category
C73584
G
Generic Name
ASENAPINE MALEATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateAugust 26, 2021
FDA Product Classification
INGREDIENTS (8)
ASENAPINE MALEATEActive
Quantity: 5 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 8/26/2021
**WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS**
****See full prescribing information for complete boxed warning.
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 8/26/2021
1 INDICATIONS AND USAGE
Asenapine sublingual tablets are indicated for:
- Schizophrenia in adults [see Clinical Studies (14.1)]
- Bipolar I disorder [see Clinical Studies (14.2)]
- Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age
- Adjunctive treatment to lithium or valproate in adults
- Maintenance monotherapy treatment in adults
Key Highlight
Asenapine sublingual tablets are an atypical antipsychotic indicated for (1):
- Schizophrenia in adults
- Bipolar I disorder
- Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age
- Adjunctive treatment to lithium or valproate in adults
- Maintenance monotherapy treatment in adults