Memantine Hydrochloride

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

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
(click image for full-size original)

Memantine Hydrochloride Extended-release Capsules, 14 mg

70771-1322-3

30 Counts

Memantine Hydrochloride Extended-Release Capsules, 14 mg
(click image for full-size original)

Memantine Hydrochloride Extended-release Capsules, 21 mg

NDC 70771-1323-3

30 Counts

Memantine Hydrochloride Extended-release Capsules, 21 mg
(click image for full-size original)

Memantine Hydrochloride Extended-release Capsules, 28 mg

NDC 70771-1324-3

30 Counts

Memantine Hydrochloride Extended-release Capsules, 28 mg
(click image for full-size original)
MEMANTINE HYDROCHLORIDE
memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1321
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
AMMONIA
ALCOHOL
BUTYL ALCOHOL
ETHYLCELLULOSE (7 MPA.S)
GELATIN
HYPROMELLOSES
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SUCROSE
TALC
TRIETHYL CITRATE
TITANIUM DIOXIDE
WATER
Product Characteristics
Color WHITE (WHITE) , WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code 546
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1321-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1321-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1321-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1321-2)
3 NDC:70771-1321-2 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1321-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203293 04/08/2018
MEMANTINE HYDROCHLORIDE
memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1322
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
AMMONIA
ALCOHOL
BUTYL ALCOHOL
ETHYLCELLULOSE (7 MPA.S)
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW
GELATIN
HYPROMELLOSES
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SUCROSE
TALC
TRIETHYL CITRATE
TITANIUM DIOXIDE
WATER
Product Characteristics
Color BLUE (LIGHT-BLUE) , GREEN (GREEN) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code 547
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1322-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1322-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1322-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1322-2)
3 NDC:70771-1322-2 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1322-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203293 04/08/2018
MEMANTINE HYDROCHLORIDE
memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1323
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
AMMONIA
ALCOHOL
BUTYL ALCOHOL
ETHYLCELLULOSE (7 MPA.S)
FERROSOFERRIC OXIDE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
GELATIN
HYPROMELLOSES
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SUCROSE
TALC
TRIETHYL CITRATE
TITANIUM DIOXIDE
WATER
Product Characteristics
Color WHITE (WHITE) , GREEN (GREEN) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code 548
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1323-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1323-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1323-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1323-2)
3 NDC:70771-1323-2 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1323-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203293 04/08/2018
MEMANTINE HYDROCHLORIDE
memantine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1324
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
AMMONIA
ALCOHOL
BUTYL ALCOHOL
ETHYLCELLULOSE (7 MPA.S)
FERROSOFERRIC OXIDE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
GELATIN
HYPROMELLOSES
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SUCROSE
TALC
TRIETHYL CITRATE
TITANIUM DIOXIDE
WATER
Product Characteristics
Color GREEN (LIGHT-GREEN) , GREEN (LIGHT-GREEN) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code 549
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1324-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1324-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1324-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1324-2)
3 NDC:70771-1324-2 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1324-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203293 04/08/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1321), ANALYSIS (70771-1322), ANALYSIS (70771-1323), ANALYSIS (70771-1324), MANUFACTURE (70771-1321), MANUFACTURE (70771-1322), MANUFACTURE (70771-1323), MANUFACTURE (70771-1324)

Revised: 09/2020 Cadila Healthcare Limited

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