Namenda XR (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 0456-3414-33
30 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules14 mg

NDC 0456-3414-33
30 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules
14 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0456-3414-90
90 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules14 mg

PRINCIPAL DISPLAY PANEL
NDC 0456-3414-90
90 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules
14 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0456-3421-33
30 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules21 mg

NDC 0456-3421-33
30 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules
21 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0456-3428-33
30 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules28 mg

NDC 0456-3428-33
30 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules
28 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0456-3428-90
90 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules28 mg

PRINCIPAL DISPLAY PANEL
NDC 0456-3428-90
90 capsules
Rx only
Once-Daily
Namenda XR®
(memantine HCI) extended release capsules
28 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0456-3400-29
Titration Pack
Once-Daily
Namenda XR®(memantine HCI) extended release capsules

PRINCIPAL DISPLAY PANEL
NDC 0456-3400-29
Titration Pack
Once-Daily

Namenda XR®
(memantine HCI) extended release capsules
(click image for full-size original)
NAMENDA XR memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-3407
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
sucrose
povidone K30
hypromellose 2910 (15 MPA.S)
talc
polyethylene glycol 400
POLYETHYLENE GLYCOL 8000
ETHYLCELLULOSE (100 MPA.S)
AMMONIA
OLEIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color yellow (yellow (opaque)) Score no score
Shape CAPSULE (CAPSULE) Size 4mm
Flavor Imprint Code FLI;7;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0456-3407-33 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 10/31/2011 07/31/2022
NAMENDA XR memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-3414
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
sucrose
povidone K30
hypromellose 2910 (15 MPA.S)
talc
polyethylene glycol 400
POLYETHYLENE GLYCOL 8000
ETHYLCELLULOSE (100 MPA.S)
AMMONIA
GELATIN, UNSPECIFIED
MEDIUM-CHAIN TRIGLYCERIDES
OLEIC ACID
Product Characteristics
Color yellow (yellow) , green (dark green (opaque)) Score no score
Shape CAPSULE (CAPSULE) Size 4mm
Flavor Imprint Code FLI;14;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0456-3414-33 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0456-3414-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0456-3414-63 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (0456-3414-11)
3 NDC:0456-3414-11 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0456-3414-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 10/31/2011
NAMENDA XR memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-3421
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
sucrose
povidone K30
hypromellose 2910 (15 MPA.S)
talc
polyethylene glycol 400
POLYETHYLENE GLYCOL 8000
ETHYLCELLULOSE (100 MPA.S)
AMMONIA
OLEIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color white (white to off-white) , green (dark green (opaque)) Score no score
Shape CAPSULE (CAPSULE) Size 4mm
Flavor Imprint Code FLI;21;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0456-3421-33 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 10/31/2011
NAMENDA XR memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-3428
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
sucrose
povidone K30
hypromellose 2910 (15 MPA.S)
talc
polyethylene glycol 400
POLYETHYLENE GLYCOL 8000
ETHYLCELLULOSE (100 MPA.S)
AMMONIA
OLEIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color green (dark green (opaque)) Score no score
Shape CAPSULE (CAPSULE) Size 3mm
Flavor Imprint Code FLI;28;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0456-3428-33 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0456-3428-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0456-3428-63 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (0456-3428-11)
3 NDC:0456-3428-11 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0456-3428-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 10/31/2011
NAMENDA XR memantine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-3400
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0456-3400-29 1 KIT in 1 BLISTER PACK None
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
NAMENDA XR 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
sucrose
povidone K30
hypromellose 2910 (15 MPA.S)
talc
polyethylene glycol 400
polyethylene glycol 8000
ethylcellulose (100 MPA.S)
ammonia
OLEIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color yellow (YELLOW (OPAQUE)) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code FLI;7;mg
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 09/15/2011
Part 2 of 4
NAMENDA XR 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
sucrose
povidone K30
hypromellose 2910 (15 MPA.S)
talc
polyethylene glycol 400
polyethylene glycol 8000
ethylcellulose (100 MPA.S)
ammonia
OLEIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color yellow (YELLOW) , green (DARK GREEN (OPAQUE)) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code FLI;14;mg
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 09/15/2011
Part 3 of 4
NAMENDA XR 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
sucrose
povidone K30
hypromellose 2910 (15 MPA.S)
talc
polyethylene glycol 400
polyethylene glycol 8000
ethylcellulose (100 MPA.S)
ammonia
OLEIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color white (WHITE TO OFF-WHITE) , green (DARK GREEN (OPAQUE)) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code FLI;21;mg
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 09/15/2011
Part 4 of 4
NAMENDA XR 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
sucrose
povidone K30
hypromellose 2910 (15 MPA.S)
talc
polyethylene glycol 400
polyethylene glycol 8000
ethylcellulose (100 MPA.S)
ammonia
OLEIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color green (DARK GREEN (OPAQUE)) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code FLI;28;mg
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 09/15/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 09/15/2011 12/31/2018
Labeler — Allergan, Inc. (144796497)

Revised: 11/2019 Allergan, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.