Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Vivimed Life Sciences Private Limited
Strides Pharma Science Limited
860477684
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
64380-905Application Number
ANDA202710Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 13, 2023ClarithromycinActive
Code: H1250JIK0AClass: ACTIBQuantity: 250 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
CLARITHROMYCIN
Product Details
NDC Product Code
64380-906Application Number
ANDA202710Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 13, 2023CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ClarithromycinActive
Code: H1250JIK0AClass: ACTIBQuantity: 500 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT