CLARITHROMYCIN
Clarithromycin Tablets These highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN t ablets , for oral use Initial U.S. Approval: 1991
Approved
Approval ID
99d2fd6b-39ca-42f9-ad06-30e7fbc22c47
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2022
Manufacturers
FDA
Chartwell RX, LLC.
DUNS: 079394054
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 Code62135-615
Application NumberANDA065384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CLARITHROMYCINActive
Quantity: 500 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB
Clarithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-616
Application NumberANDA065384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CLARITHROMYCINActive
Quantity: 250 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB