Label: GALANTAMINE tablet, film coated
-
NDC Code(s):
65841-755-01,
65841-755-10,
65841-755-14,
65841-755-77, view more65841-756-01, 65841-756-10, 65841-756-14, 65841-756-77, 65841-757-01, 65841-757-10, 65841-757-14, 65841-757-77
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 30, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GALANTAMINE
galantamine tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-755 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA) GALANTAMINE 4 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) 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 Marketing Start Date Marketing End Date 1 NDC:65841-755-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2011 2 NDC:65841-755-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2011 3 NDC:65841-755-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2011 4 NDC:65841-755-77 10 in 1 CARTON 10/10/2011 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078898 10/10/2011 GALANTAMINE
galantamine tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-756 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA) GALANTAMINE 8 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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 Marketing Start Date Marketing End Date 1 NDC:65841-756-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2011 2 NDC:65841-756-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2011 3 NDC:65841-756-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2011 4 NDC:65841-756-77 10 in 1 CARTON 10/10/2011 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078898 10/10/2011 GALANTAMINE
galantamine tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-757 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA) GALANTAMINE 12 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) 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 Marketing Start Date Marketing End Date 1 NDC:65841-757-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2011 2 NDC:65841-757-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2011 3 NDC:65841-757-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2011 4 NDC:65841-757-77 10 in 1 CARTON 10/10/2011 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 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 Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-755, 65841-756, 65841-757) , MANUFACTURE(65841-755, 65841-756, 65841-757)
