Asenapine (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2.5 mg

NDC 46708-544-60
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-25mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 5 mg

NDC 46708-198-60
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-5mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg

NDC 46708-199-60
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-10mg
(click image for full-size original)

ASENAPINE asenapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-544
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
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
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:46708-544-60 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (46708-544-10)
1 NDC:46708-544-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (46708-544-60)
2 NDC:46708-544-31 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (46708-544-31)
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:46708-198
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
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
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:46708-198-60 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (46708-198-10)
1 NDC:46708-198-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (46708-198-60)
2 NDC:46708-198-31 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (46708-198-31)
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:46708-199
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
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
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:46708-199-60 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (46708-199-10)
1 NDC:46708-199-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (46708-199-60)
2 NDC:46708-199-31 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (46708-199-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206098 12/10/2020
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-198), MANUFACTURE (46708-199), MANUFACTURE (46708-544)

Revised: 01/2023 Alembic Pharmaceuticals Limited

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