Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp.
Rebel Distributors Corp.
118802834
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clarithromycin
Product Details
NDC Product Code
21695-558Application Number
ANDA065136Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 25, 2008ClarithromycinActive
Code: H1250JIK0AClass: ACTIBQuantity: 500 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Clarithromycin
Product Details
NDC Product Code
21695-557Application Number
ANDA065144Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 25, 2008ClarithromycinActive
Code: H1250JIK0AClass: ACTIBQuantity: 250 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT