Amlodipine Besylate (Page 5 of 5)

Principal Display Panel — 2.5 mg Tablets

Amlodipine Besylate Tablets, USP
2.5 mg/30 tabletsNDC 0143-9959-30

Amlodipine besylate tablets, 2.5 mg/30 tablets
(click image for full-size original)

Principal Display Panel — 5 mg Tablets

Amlodipine besylate tablets, USP
5 mg/30 tabletsNDC 0143-9960-30

Amlodipine Besylate Tablets, USP 5 mg/30 Tablets
(click image for full-size original)

Principal Display Panel — 10 mg Tablets

Amlodipine besylate tablets, USP
10 mg/30 tabletsNDC 0143-9961-30

Amlodipine Besylate Tablets, USP 10 mg/30 Tablets
(click image for full-size original)

AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9959
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
Product Characteristics
Color WHITE Score no score
Shape DIAMOND Size 7mm
Flavor Imprint Code W59
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9959-01 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:0143-9959-09 90 TABLET (90 TABLET) in 1 BOTTLE None
3 NDC:0143-9959-30 30 TABLET (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077771 04/12/2011
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9960
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
Product Characteristics
Color WHITE Score no score
Shape OCTAGON (8 SIDED) Size 9mm
Flavor Imprint Code W60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9960-01 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:0143-9960-09 90 TABLET (90 TABLET) in 1 BOTTLE None
3 NDC:0143-9960-30 30 TABLET (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077771 04/12/2011
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9961
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9961-01 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:0143-9961-09 90 TABLET (90 TABLET) in 1 BOTTLE None
3 NDC:0143-9961-30 30 TABLET (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077771 04/12/2011
Labeler — West-ward Pharmaceutical Corp (001230762)
Establishment
Name Address ID/FEI Operations
Hikma Pharmaceutical 534661645 MANUFACTURE

Revised: 04/2011 West-ward Pharmaceutical Corp

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