Amlodipine besylate tablet

Ingredients and appearance - Product information

Amlodipine besylate tablet- Amlodipine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 54458-903
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Amlodipine besylate ( UNII: 864V2Q084H)( Amlodipine - UNII: 1J444QC288 ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Calcium phosphate, dibasic, anhydrous ( UNII: L11K75P92J)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color WHITE (White (OFF-WHITE)) Imprint Code 209
Score 1 Shape ROUND
Size 11 mm


# Item Code Package Description Marketing Start Date
1 NDC: 54458-903-02 30 in 1 BLISTER PACK 2012/09/14

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078925 USA 2012/09/14

Labeler - International Laboratories, Inc.( 023569924)


Name ID/FEI Business Operations
International Laboratories, Inc. 023569924 MANUFACTURE( 54458-903)