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Galantamine

Generic name: Galantamine hydrobromide
Dosage form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on Aug 1, 2020.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-755-14 in bottle of 60 tablets

Galantamine Tablets USP, 4 mg

Rx only

60 tablets

NDC 65841-756-14 in bottle of 60 tablets

Galantamine Tablets USP, 8 mg

Rx only

60 tablets

NDC 65841-757-14 in bottle of 60 tablets

Galantamine Tablets USP, 12 mg

Rx only

60 tablets

Galantamine
Galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-755
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Galantamine HYDROBROMIDE (Galantamine) Galantamine 4 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SILICON DIOXIDE
TITANIUM DIOXIDE
FERRIC OXIDE RED
CROSPOVIDONE (15 MPA.S AT 5%)
Product Characteristics
Color PINK (LIGHT PINK) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code 77;Z
Contains
Packaging
# Item Code Package Description
1 NDC:65841-755-14 60 TABLET, FILM COATED in 1 BOTTLE
2 NDC:65841-755-01 100 TABLET, FILM COATED in 1 BOTTLE
3 NDC:65841-755-10 1000 TABLET, FILM COATED in 1 BOTTLE
4 NDC:65841-755-77 10 BLISTER PACK in 1 CARTON
4 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078898 10/10/2011
Galantamine
Galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-756
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Galantamine HYDROBROMIDE (Galantamine) Galantamine 8 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 78;Z
Contains
Packaging
# Item Code Package Description
1 NDC:65841-756-14 60 TABLET, FILM COATED in 1 BOTTLE
2 NDC:65841-756-01 100 TABLET, FILM COATED in 1 BOTTLE
3 NDC:65841-756-10 1000 TABLET, FILM COATED in 1 BOTTLE
4 NDC:65841-756-77 10 BLISTER PACK in 1 CARTON
4 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078898 10/10/2011
Galantamine
Galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-757
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Galantamine HYDROBROMIDE (Galantamine) Galantamine 12 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SILICON DIOXIDE
TITANIUM DIOXIDE
HYPROMELLOSES
Product Characteristics
Color WHITE (OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 79;Z
Contains
Packaging
# Item Code Package Description
1 NDC:65841-757-14 60 TABLET, FILM COATED in 1 BOTTLE
2 NDC:65841-757-01 100 TABLET, FILM COATED in 1 BOTTLE
3 NDC:65841-757-10 1000 TABLET, FILM COATED in 1 BOTTLE
4 NDC:65841-757-77 10 BLISTER PACK in 1 CARTON
4 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078898 10/10/2011
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS(65841-755, 65841-756, 65841-757), MANUFACTURE(65841-755, 65841-756, 65841-757)
Cadila Healthcare Limited