Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Lifesciences Limited
918596198
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Lifesciences Limited
Zydus Lifesciences Limited
918596198
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ribavirin
Product Details
NDC Product Code
65841-046Application Number
ANDA077094Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 27, 2023CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
RibavirinActive
Code: 49717AWG6KClass: ACTIBQuantity: 200 mg in 1 1
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Ribavirin
Product Details
NDC Product Code
65841-129Application Number
ANDA077094Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 27, 2023RibavirinActive
Code: 49717AWG6KClass: ACTIBQuantity: 600 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Ribavirin
Product Details
NDC Product Code
65841-632Application Number
ANDA077094Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 27, 2023CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
RibavirinActive
Code: 49717AWG6KClass: ACTIBQuantity: 500 mg in 1 1
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Ribavirin
Product Details
NDC Product Code
65841-603Application Number
ANDA077094Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 27, 2023RibavirinActive
Code: 49717AWG6KClass: ACTIBQuantity: 400 mg in 1 1
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT