Amlodipine Besylate (Page 5 of 5)

16. HOW SUPPLIED/STORAGE AND HANDLING

Product: 68151-0995

NDC: 68151-0995-9 1 TABLET in a PACKAGE

Amlodipine Besylate 10 MG TAB

Label Image8352ab43-figure-018352ab43-figure-028352ab43-figure-03Label Image
AMLODIPINE BESYLATE
amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-0995(NDC:31722-239)
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
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 239;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-0995-9 1 TABLET in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077955 01/01/2011
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-0995)

Revised: 07/2017 Carilion Materials Management

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