Galantamine

GALANTAMINE — galantamine hydrobromide tablet, film coated
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-755-14 in bottle of 60 tablets

Galantamine Tablets USP, 4 mg

R_x only

60 tablets

NDC 65841-756-14 in bottle of 60 tablets

Galantamine Tablets USP, 8 mg

R_x only

60 tablets

NDC 65841-757-14 in bottle of 60 tablets

Galantamine Tablets USP, 12 mg

R_x only

60 tablets

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 — Zydus Lifesciences Limited (918596198)

Registrant — Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		918596198	ANALYSIS (65841-755), ANALYSIS (65841-756), ANALYSIS (65841-757), MANUFACTURE (65841-755), MANUFACTURE (65841-756), MANUFACTURE (65841-757)

Revised: 10/2022 Zydus Lifesciences Limited