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Indapamide

Indapamide

Approved
Approval ID

92c7be7d-8c89-476a-b131-9deef76ed016

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 29, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

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 Code21695-576
Application NumberANDA074461
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indapamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2006
FDA Product Classification

INGREDIENTS (13)

INDAPAMIDEActive
Quantity: 1.25 mg in 1 1
Code: F089I0511L
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT

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Indapamide - FDA Drug Approval Details