MEMANTINE HYDROCHLORIDE- memantine hydrochloride tablet, film coated 
Cadila Healthcare Limited

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MEMANTINE HYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1119-1 in bottle of 100 tablets

Memantine Hydrochloride Tablets USP, 5 mg

Rx only

100 tablets

Memantine Hydrochloride Tablets

NDC 70771-1120-1 in bottle of 100 tablets

Memantine Hydrochloride Tablets USP, 10 mg

Rx only

100 tablets

Memantine Hydrochloride Tablets
MEMANTINE HYDROCHLORIDE 
memantine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1119
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size9mm
FlavorImprint Code ZF;41
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1119-4100 in 1 CARTON09/28/2017
1NDC:70771-1119-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70771-1119-660 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
3NDC:70771-1119-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
4NDC:70771-1119-5500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
5NDC:70771-1119-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09096109/28/2017
MEMANTINE HYDROCHLORIDE 
memantine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size11mm
FlavorImprint Code ZF;40
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1120-660 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
2NDC:70771-1120-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
3NDC:70771-1120-5500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
4NDC:70771-1120-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
5NDC:70771-1120-41000 in 1 CARTON09/28/2017
5NDC:70771-1120-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09096109/28/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1119, 70771-1120) , MANUFACTURE(70771-1119, 70771-1120)

Revised: 9/2020
Document Id: 94bb15a9-3bea-44df-acbf-ac5497d27d7c
Set id: 514421f3-f525-43e8-aecc-8b2bbffd00dc
Version: 5
Effective Time: 20200901
 
Cadila Healthcare Limited