NDC Code(s) : 62332-544-10, 62332-544-60, 62332-544-31, 62332-198-10, 62332-198-60, 62332-198-31, 62332-199-10, 62332-199-60, 62332-199-31
Packager : Alembic Pharmaceuticals Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Asenapine Asenapine TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-544
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASENAPINE(UNII: JKZ19V908O)
(ASENAPINE - UNII:JKZ19V908O) 		ASENAPINE2.5 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30(UNII: U725QWY32X)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MANNITOL(UNII: 3OWL53L36A)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND Size 4 mm
Flavor Imprint Code L;70
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-544-6060 in 1 CARTON 20/07/2021
1NDC:62332-544-1010 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:62332-544-31100 in 1 CARTON 20/07/2021
210 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206098 07/20/2021
Asenapine Asenapine TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-198
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASENAPINE(UNII: JKZ19V908O)
(ASENAPINE - UNII:JKZ19V908O) 		ASENAPINE5 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30(UNII: U725QWY32X)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MANNITOL(UNII: 3OWL53L36A)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 464
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-198-6060 in 1 CARTON 12/10/2020
1NDC:62332-198-1010 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:62332-198-31100 in 1 CARTON 12/10/2020
210 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206098 12/10/2020
Asenapine Asenapine TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-199
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASENAPINE(UNII: JKZ19V908O)
(ASENAPINE - UNII:JKZ19V908O) 		ASENAPINE10 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30(UNII: U725QWY32X)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MANNITOL(UNII: 3OWL53L36A)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 465
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-199-6060 in 1 CARTON 12/10/2020
1NDC:62332-199-1010 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:62332-199-31100 in 1 CARTON 12/10/2020
210 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206098 12/10/2020

LABELER - Alembic Pharmaceuticals Inc.(079288842)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE(62332-198, 62332-199, 62332-544)

PRINCIPAL DISPLAY PANEL

NDC 62332-544-60
Asenapine Sublingual Tablets
2.5 mg
For sublingual (under the tongue) use only.
Do not split, cut or crush tablet.
Do not chew or swallow tablet.
Fragile: Do not push tablet through tablet pack.

Rx only
Alembic
60 Tablets - 6 blister cards of 10 tablets each

asenapine-25-mg

PRINCIPAL DISPLAY PANEL

NDC 62332-198-60
Asenapine Sublingual Tablets
5 mg 
For sublingual (under the tongue) use only.
Do not split, cut or crush tablet.
Do not chew or swallow tablet.
Fragile: Do not push tablet through tablet pack
Rx only
Alembic
60 Tablets - 6 blister cards of 10 tablets each

asenapine-5-mg

 


PRINCIPAL DISPLAY PANEL

NDC 62332-199-60
Asenapine Sublingual Tablets
10 mg 
For sublingual (under the tongue) use only.
Do not split, cut or crush tablet.
Do not chew or swallow tablet.
Fragile: Do not push tablet through tablet pack
Rx only
Alembic
60 Tablet s - 6 blister cards of 10 tablets each

asenapine-10-mg