Asenapine

Basic Information

Product Name

Asenapine

FDA Product Code

51991-358

Regulatory Information

NDC Product Code

51991-358

Application Number

ANDA205960

Marketing Category

C73584

Effective Date

January 31, 2024

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ASENAPINE MALEATE

Quantity: 5 mg in 1 1

Code: CU9463U2E2

Class Code: ACTIM

ASPARTAME

Code: Z0H242BBR1

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 2165RE0K14

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

Active Moieties

Code: JKZ19V908O

Asenapine

Basic Information

Regulatory Information

Company Information

Active Ingredients

ASPARTAME

SILICON DIOXIDE

CROSPOVIDONE (120 .MU.M)

MICROCRYSTALLINE CELLULOSE

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED

MAGNESIUM STEARATE

POVIDONE K30

Active Moieties

ASENAPINE