NDC Code(s) : 42806-055-09, 42806-055-05, 42806-055-10, 42806-056-09, 42806-056-05, 42806-056-10, 42806-057-09, 42806-057-05, 42806-057-10
Packager : Epic Pharma, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AMLODIPINE BESYLATEAMLODIPINE BESYLATE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-055
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE2.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code E55
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-055-0990 in 1 BOTTLE Type 0: Not a Combination Product25/04/2011
2NDC:42806-055-05500 in 1 BOTTLE Type 0: Not a Combination Product25/04/2011
3NDC:42806-055-101000 in 1 BOTTLE Type 0: Not a Combination Product25/04/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078552 04/25/2011
AMLODIPINE BESYLATEAMLODIPINE BESYLATE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code E56
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-056-0990 in 1 BOTTLE Type 0: Not a Combination Product25/04/2011
2NDC:42806-056-05500 in 1 BOTTLE Type 0: Not a Combination Product25/04/2011
3NDC:42806-056-101000 in 1 BOTTLE Type 0: Not a Combination Product25/04/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078552 04/25/2011
AMLODIPINE BESYLATEAMLODIPINE BESYLATE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code E57
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-057-0990 in 1 BOTTLE Type 0: Not a Combination Product25/04/2011
2NDC:42806-057-05500 in 1 BOTTLE Type 0: Not a Combination Product25/04/2011
3NDC:42806-057-101000 in 1 BOTTLE Type 0: Not a Combination Product25/04/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078552 04/25/2011

LABELER - Epic Pharma, LLC(827915443)

PRINCIPAL DISPLAY PANEL

Amlodipine Besylate Tablets USP, 2.5 mg

PHARMACIST: Dispense the accompanying Patient Information leaflet to each patient.

Rx Only

1000 Tablets

2.5mg-1000ct.jpg

PRINCIPAL DISPLAY PANEL

Amlodipine Besylate Tablets USP, 5 mg

PHARMACIST: Dispense the accompanying Patient Information leaflet to each patient.

Rx Only

500 Tablets

5mg-500ct.jpg

PRINCIPAL DISPLAY PANEL

Amlodipine Besylate Tablets USP, 10 mg

PHARMACIST: Dispense the accompanying Patient Information leaflet to each patient.

Rx Only

90 Tablets

10mg-90ct.jpg