Amlodipine Besylate
These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE besylate tablets for oral administration Initial U.S. Approval: 1992
Approved
Approval ID
6cf5ece4-4d4e-478e-be8f-bd198c6edc5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 3
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 Code71335-0945
Application NumberANDA078925
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2022
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Amlodipine besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0934
Application NumberANDA078925
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2022
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Amlodipine besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0890
Application NumberANDA078925
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2022
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT