Indapamide
Indapamide Tablets USP Rx only
Approved
Approval ID
deb83f97-6c61-4a09-bed6-18dcf1183405
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2021
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Indapamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-511
Application NumberANDA074299
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indapamide
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2017
FDA Product Classification
INGREDIENTS (10)
INDAPAMIDEActive
Quantity: 2.5 mg in 1 1
Code: F089I0511L
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Indapamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-510
Application NumberANDA074299
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indapamide
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2017
FDA Product Classification
INGREDIENTS (11)
INDAPAMIDEActive
Quantity: 1.25 mg in 1 1
Code: F089I0511L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT