Asenapine (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2.5 mg

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
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 5 mg

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
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg

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 Tablets — 6 blister cards of 10 tablets each

asenapine-10-mg
(click image for full-size original)

ASENAPINE asenapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-544
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASENAPINE (ASENAPINE) ASENAPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
BUTYLATED HYDROXYTOLUENE
BUTYLATED HYDROXYANISOLE
MANNITOL
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
SODIUM STEARYL FUMARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND Size 4mm
Flavor Imprint Code L;70
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-544-60 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (62332-544-10)
1 NDC:62332-544-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (62332-544-60)
2 NDC:62332-544-31 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (62332-544-31)
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 Item Code (Source) NDC:62332-198
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASENAPINE (ASENAPINE) ASENAPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
BUTYLATED HYDROXYTOLUENE
BUTYLATED HYDROXYANISOLE
MANNITOL
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
SODIUM STEARYL FUMARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 464
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-198-60 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (62332-198-10)
1 NDC:62332-198-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (62332-198-60)
2 NDC:62332-198-31 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (62332-198-31)
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 Item Code (Source) NDC:62332-199
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASENAPINE (ASENAPINE) ASENAPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
BUTYLATED HYDROXYTOLUENE
BUTYLATED HYDROXYANISOLE
MANNITOL
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
SODIUM STEARYL FUMARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 465
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-199-60 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (62332-199-10)
1 NDC:62332-199-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (62332-199-60)
2 NDC:62332-199-31 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (62332-199-31)
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 Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (62332-198), MANUFACTURE (62332-199), MANUFACTURE (62332-544)

Revised: 09/2021 Alembic Pharmaceuticals Inc.

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