Galantamine: Package Insert and Label Information

GALANTAMINE- galantamine hydrobromide tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-755-14 in bottle of 60 tablets

Galantamine Tablets USP, 4 mg

Rx only

60 tablets

galantamine tablets USP, 4mg
(click image for full-size original)

NDC 65841-756-14 in bottle of 60 tablets

Galantamine Tablets USP, 8 mg

Rx only

60 tablets

galantamine Tablets USP, 8mg
(click image for full-size original)

NDC 65841-757-14 in bottle of 60 tablets

Galantamine Tablets USP, 12 mg

Rx only

60 tablets

galantamine Tablets USP, 12mg
(click image for full-size original)
GALANTAMINE
galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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 Multilevel Packaging
1 NDC:65841-755-14 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-755-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-755-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-755-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-755-77)
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 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 Multilevel Packaging
1 NDC:65841-756-14 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-756-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-756-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-756-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-756-77)
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 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 Multilevel Packaging
1 NDC:65841-757-14 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-757-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-757-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-757-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-757-77)
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), ANALYSIS (65841-756), ANALYSIS (65841-757), MANUFACTURE (65841-755), MANUFACTURE (65841-756), MANUFACTURE (65841-757)

Revised: 08/2020 Cadila Healthcare Limited

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