MEMANTINE HYDROCHLORIDE (Page 6 of 6)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 7 mg (30 Capsules Bottle)

NDC 59651-404-30
Once-Daily
Memantine Hydrochloride
Extended-Release Capsules
7 mg
Rx Only 30 Capsules AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 7 mg (30 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 14 mg (30 Capsules Bottle)

NDC 59651-405-30
Once-Daily
Memantine Hydrochloride
Extended-Release Capsules
14 mg
Rx Only 30 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 14 mg (30 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 21 mg (30 Capsules Bottle)

NDC 59651-406-30
Once-Daily
Memantine Hydrochloride
Extended-Release Capsules
21 mg
Rx Only 30 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 21 mg (30 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 28 mg (30 Capsules Bottle)

NDC 59651-407-30
Once-Daily
Memantine Hydrochloride
Extended-Release Capsules
28 mg
Rx Only 30 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 28 mg (30 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — Titration Pack

NDC 59651-408-28
Titration Pack
Once-Daily
Memantine Hydrochloride
Extended-Release Capsules
Week 1: 7 mg
Week 2: 14 mg This Titration Pack includes:
Week 3: 21 mg Memantine Hydrochloride Extended-Release Capsules Week 4: 28 mg for your first 4 weeks of therapy.

For detailed dosing instructions, see inside panel

Rx Only AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- Titration Pack
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — Titration Pack Carton Label

NDC 59651-408-28
Titration Pack
Once-Daily
Memantine Hydrochloride
Extended-Release Capsules
Week 1: 7 mg
Week 2: 14 mg This Titration Pack includes:
Week 3: 21 mg Memantine Hydrochloride Extended-Release Capsules
Week 4: 28 mg for your first 4 weeks of therapy.
For detailed dosing instructions, see inside panel Rx Only AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- Titration Pack Carton
(click image for full-size original)
MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-404
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 7 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (20 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
POLYETHYLENE GLYCOL 6000
STARCH, CORN
SUCROSE
TALC
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color YELLOW (Yellow Opaque Cap) , YELLOW (Yellow Opaque Body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code M;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-404-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:59651-404-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214651 08/09/2021
MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-405
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 14 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (20 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
POLYETHYLENE GLYCOL 6000
STARCH, CORN
SUCROSE
TALC
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color YELLOW (Yellow Opaque Cap) , GREEN (Dark Green Opaque Body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code M;14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-405-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:59651-405-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214651 08/09/2021
MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-406
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 21 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (20 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
POLYETHYLENE GLYCOL 6000
STARCH, CORN
SUCROSE
TALC
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color WHITE (White to Off-white Cap) , GREEN (Dark Green Opaque Body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code M;21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-406-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:59651-406-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214651 08/09/2021
MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-407
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 28 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (20 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
POLYETHYLENE GLYCOL 6000
STARCH, CORN
SUCROSE
TALC
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color GREEN (Dark Green Opaque Cap) , GREEN (Dark Green Opaque Body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code M;28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-407-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:59651-407-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214651 08/09/2021
MEMANTINE HYDROCHLORIDE memantine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-408
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-408-28 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (59651-408-28)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 7
Part 2 7
Part 3 7
Part 4 7
Part 1 of 4
MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 7 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (20 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
POLYETHYLENE GLYCOL 6000
STARCH, CORN
SUCROSE
TALC
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color YELLOW (Yellow Opaque Cap) , YELLOW (Yellow Opaque Body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code M;7
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214651 08/09/2021
Part 2 of 4
MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 14 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (20 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
POLYETHYLENE GLYCOL 6000
STARCH, CORN
SUCROSE
TALC
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color YELLOW (Yellow Opaque Cap) , GREEN (Dark Green Opaque Body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code M;14
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214651 08/09/2021
Part 3 of 4
MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 21 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (20 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
POLYETHYLENE GLYCOL 6000
STARCH, CORN
SUCROSE
TALC
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color WHITE (White to Off-white Cap) , GREEN (Dark Green Opaque Body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code M;21
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214651 08/09/2021
Part 4 of 4
MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 28 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (20 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
POLYETHYLENE GLYCOL 6000
STARCH, CORN
SUCROSE
TALC
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color GREEN (Dark Green Opaque Cap) , GREEN (Dark Green Opaque Body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code M;28
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214651 08/09/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214651 08/09/2021
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
APL HEALTHCARE LIMITED 650918514 ANALYSIS (59651-404), ANALYSIS (59651-405), ANALYSIS (59651-406), ANALYSIS (59651-407), ANALYSIS (59651-408), MANUFACTURE (59651-404), MANUFACTURE (59651-405), MANUFACTURE (59651-406), MANUFACTURE (59651-407), MANUFACTURE (59651-408)

Revised: 08/2021 Aurobindo Pharma Limited

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