Amlodipine Besylate
Approved
Approval ID
a10fa641-ac6b-466d-bcba-31c678a74be8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 12, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amlodipine besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0653
Application NumberANDA076418
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (5)
AMLODIPINE BESYLATEActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
amlodipine besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0200
Application NumberANDA077955
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (5)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT