Famotidine (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-20 mg

Famotidine Tablets USP 20 mg (30 Tablets in 1 Bottle) Each Film Coated Tablet Contains:
Famotidine USP 20 mg 46708-293-30

20 mg30's bottle pack
(click image for full-size original)

20 mg30’s bottle pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-40 mg

Famotidine Tablets USP 40 mg (30 Tablets in 1 Bottle)
Each Film Coated Tablet Contains:
Famotidine USP 40 mg46708-294-30

40 mg30's bottle pack
(click image for full-size original)
FAMOTIDINE famotidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-293
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
LECITHIN, SOYBEAN
POLYETHYLENE GLYCOL 3350
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 6mm
Flavor Imprint Code L113;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-293-30 30 TABLET in 1 BOTTLE None
2 NDC:46708-293-31 100 TABLET in 1 BOTTLE None
3 NDC:46708-293-71 500 TABLET in 1 BOTTLE None
4 NDC:46708-293-91 1000 TABLET in 1 BOTTLE None
5 NDC:46708-293-10 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078916 01/29/2016
FAMOTIDINE famotidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-294
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
LECITHIN, SOYBEAN
POLYETHYLENE GLYCOL 3350
FERRIC OXIDE RED
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L114;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-294-30 30 TABLET in 1 BOTTLE None
2 NDC:46708-294-31 100 TABLET in 1 BOTTLE None
3 NDC:46708-294-71 500 TABLET in 1 BOTTLE None
4 NDC:46708-294-91 1000 TABLET in 1 BOTTLE None
5 NDC:46708-294-10 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078916 01/29/2016
Labeler — Alembic Pharmaceuticals Limited (650574663)
Registrant — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-293), MANUFACTURE (46708-294)

Revised: 01/2023 Alembic Pharmaceuticals Limited

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