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 administrationInitial U.S. Approval:1992
Approved
Approval ID
c262dedb-1d13-4447-9355-f11e1dbbfb4d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2023
Manufacturers
FDA
Quallent Pharmaceuticals Health LLC
DUNS: 815564528
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
NDC Product Code82009-028
Application NumberANDA077073
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 15, 2023
Generic NameAMLODIPINE BESYLATE
INGREDIENTS (6)
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMLODIPINE BESYLATE
PRODUCT DETAILS
NDC Product Code82009-027
Application NumberANDA077073
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 15, 2023
Generic NameAMLODIPINE BESYLATE
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMLODIPINE BESYLATE
PRODUCT DETAILS
NDC Product Code82009-026
Application NumberANDA077073
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 15, 2023
Generic NameAMLODIPINE BESYLATE
INGREDIENTS (6)
AMLODIPINE BESYLATEActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT