Clarithromycin
These highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. Clarithromycin tablets USP, for oral use Initial U.S. Approval: 1991
Approved
Approval ID
9bf207c0-86eb-4f3b-92e7-f65f3fccd5a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clarithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-1932
Application NumberANDA203584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CLARITHROMYCINActive
Quantity: 500 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
Clarithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-1931
Application NumberANDA203584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CLARITHROMYCINActive
Quantity: 250 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB