Clarithromycin
Clarithromycin Tablets, USP
Approved
Approval ID
f3a50f13-b028-4135-8f20-bfb62a9bc0a9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-558
Application NumberANDA065136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2008
FDA Product Classification
INGREDIENTS (10)
clarithromycinActive
Quantity: 500 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Clarithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-557
Application NumberANDA065144
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2008
FDA Product Classification
INGREDIENTS (10)
clarithromycinActive
Quantity: 250 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT