ROCHLORIDE 21 mg
Inactive Ingredients
Ingredient Name Strength
sucrose (UNII: C151H8M554)
povidone K30 (UNII: U725QWY32X)
hypromellose 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
talc (UNII: 7SEV7J4R1U)
polyethylene glycol 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)
AMMONIA (UNII: 5138Q19F1X)
Product Characteristics
Color WHITE (white to off-white) , GREEN (dark green (opaque)) Score no score
Shape CAPSULE (CAPSULE) Size 4mm
Flavor PEPPERMINT (PEPPERMINT) Imprint Code FLI;21;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0456-3421-33 30 in 1 BOTTLE
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (memantine - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE 28 mg
Inactive Ingredients
Ingredient Name Strength
sucrose (UNII: C151H8M554)
povidone K30 (UNII: U725QWY32X)
hypromellose 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
talc (UNII: 7SEV7J4R1U)
polyethylene glycol 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)
AMMONIA (UNII: 5138Q19F1X)
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 Marketing Start Date Marketing End Date
1 NDC:0456-3428-33 30 in 1 BOTTLE
2 NDC:0456-3428-90 90 in 1 BOTTLE
3 NDC:0456-3428-63 10 in 1 BOX, UNIT-DOSE
3 NDC:0456-3428-11 10 in 1 BLISTER PACK
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 Marketing Start Date Marketing End Date
1 NDC:0456-3400-29 1 in 1 BLISTER PACK
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
memantine hydrochloride (UNII: J |
