Galantamine Hydrobromide (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — Label 8 mg

NDC 47335-835-83
Galantamine Hydrobromide Extended-release Capsules
8 mg
Rx only
30 Capsules SUN PHARMA

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PRINCIPAL DISPLAY PANEL — Label 16 mg

NDC 47335-836-83
Galantamine Hydrobromide Extended-release Capsules
16 mg*
Rx only
30 Capsules
SUN PHARMA

spl-galantamine-label2
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PRINCIPAL DISPLAY PANEL — Label 24mg

NDC 47335-837-83
Galantamine Hydrobromide Extended-release Capsules
24 mg*
Rx only
30 Capsules
SUN PHARMA

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GALANTAMINE HYDROBROMIDE galantamine hydrobromide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-835
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
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 835;835
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-835-83 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:47335-835-88 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:47335-835-08 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:47335-835-18 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090178 02/09/2011
GALANTAMINE HYDROBROMIDE galantamine hydrobromide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-836
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 16 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK (pink opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 836;836
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-836-83 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:47335-836-88 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:47335-836-08 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:47335-836-18 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090178 02/09/2011
GALANTAMINE HYDROBROMIDE galantamine hydrobromide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-837
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 24 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FD&C YELLOW NO. 6
Product Characteristics
Color BROWN (caramel opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 837;837
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-837-83 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:47335-837-88 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:47335-837-08 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:47335-837-18 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090178 02/09/2011
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 650445203 ANALYSIS (47335-835), ANALYSIS (47335-836), ANALYSIS (47335-837), MANUFACTURE (47335-835), MANUFACTURE (47335-836), MANUFACTURE (47335-837)

Revised: 08/2021 Sun Pharmaceutical Industries, Inc.

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