Amlodipine Besylate (Page 5 of 5)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 10135-759-90
Amlodipine Besylate Tablets, USP
2.5 mg*
Rx only
90 Tablets

lable1
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NDC 10135-759-10
Amlodipine Besylate Tablets, USP
2.5 mg*
Rx only
1000 Tablets

label2
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NDC 10135-0760-90
Amlodipine Besylate Tablets, USP
5 mg*
Rx only 90 Tablets

label3
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NDC 10135-0760-10

Amlodipine Besylate Tablets, USP
5 mg*
Rx only
1000 Tablets

label4
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NDC 10135-0761-90
Amlodipine Besylate Tablets, USP
10 mg*
Rx only 90 Tablets

label5
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NDC 10135-0761-10

Amlodipine Besylate Tablets, USP
10 mg*
Rx only 1000 Tablets

label6
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AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-759
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score no score
Shape ROUND Size 5mm
Flavor Imprint Code P41
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-759-90 90 TABLET in 1 BOTTLE None
2 NDC:10135-759-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207821 10/01/2022
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-760
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code P42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-760-90 90 TABLET in 1 BOTTLE None
2 NDC:10135-760-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207821 10/01/2022
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-761
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code P43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-761-90 90 TABLET in 1 BOTTLE None
2 NDC:10135-761-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207821 10/01/2022
Labeler — Marlex Pharmaceuticals, Inc. (782540215)

Revised: 10/2022 Marlex Pharmaceuticals, Inc.

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