MEMANTINE HYDROCHLORIDE- memantine hydrochloride capsule, extended release 
Cadila Healthcare Limited

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MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Memantine Hydrochloride Extended-release Capsules, 7 mg

NDC 70771-1321-3

30 Counts

Memantine Hydrochloride Extended-Release Capsules, 7 mg

Memantine Hydrochloride Extended-release Capsules, 14 mg

70771-1322-3

30 Counts

Memantine Hydrochloride Extended-Release Capsules, 14 mg

Memantine Hydrochloride Extended-release Capsules, 21 mg

NDC 70771-1323-3

30 Counts

Memantine Hydrochloride Extended-release Capsules, 21 mg

Memantine Hydrochloride Extended-release Capsules, 28 mg

NDC 70771-1324-3

30 Counts

Memantine Hydrochloride Extended-release Capsules, 28 mg
MEMANTINE HYDROCHLORIDE 
memantine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1321
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE7 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code 546
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1321-330 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
2NDC:70771-1321-990 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
3NDC:70771-1321-410 in 1 CARTON04/08/2018
3NDC:70771-1321-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20329304/08/2018
MEMANTINE HYDROCHLORIDE 
memantine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1322
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE14 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (LIGHT-BLUE) , GREEN (GREEN) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code 547
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1322-330 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
2NDC:70771-1322-990 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
3NDC:70771-1322-410 in 1 CARTON04/08/2018
3NDC:70771-1322-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20329304/08/2018
MEMANTINE HYDROCHLORIDE 
memantine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE21 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE) , GREEN (GREEN) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code 548
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1323-330 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
2NDC:70771-1323-990 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
3NDC:70771-1323-410 in 1 CARTON04/08/2018
3NDC:70771-1323-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20329304/08/2018
MEMANTINE HYDROCHLORIDE 
memantine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1324
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE28 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGREEN (LIGHT-GREEN) , GREEN (LIGHT-GREEN) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 549
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1324-330 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
2NDC:70771-1324-990 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
3NDC:70771-1324-410 in 1 CARTON04/08/2018
3NDC:70771-1324-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20329304/08/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1321, 70771-1322, 70771-1323, 70771-1324) , MANUFACTURE(70771-1321, 70771-1322, 70771-1323, 70771-1324)

Revised: 9/2020
Document Id: 9fdf792f-05cd-46f4-9c28-f498df165c16
Set id: ec825bef-2313-45c2-8858-b43197680155
Version: 3
Effective Time: 20200901
 
Cadila Healthcare Limited