AMLODIPINE BESYLATE
AMLODIPINE BESYLATE tablets for oral administration Initial U.S. Approval: 1992
Approved
Approval ID
6f20efca-943b-4bc2-a157-0931bd4d4585
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2024
Manufacturers
FDA
Oxford Pharmaceuticals, LLC
DUNS: 079638266
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 Code69584-021
Application NumberANDA078414
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2024
FDA Product Classification
INGREDIENTS (5)
Amlodipine BesylateActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Microcrystalline Cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
AMLODIPINE BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69584-022
Application NumberANDA078414
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2024
FDA Product Classification
INGREDIENTS (5)
Microcrystalline Cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Amlodipine BesylateActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
AMLODIPINE BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69584-023
Application NumberANDA078414
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2024
FDA Product Classification
INGREDIENTS (5)
Amlodipine BesylateActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline Cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT