Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
863362789
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythromycin
Product Details
NDC Product Code
70710-1755Application Number
ANDA215440Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 6, 2023HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ErythromycinActive
Code: 63937KV33DClass: ACTIBQuantity: 250 mg in 1 1
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7FClass: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Erythromycin
Product Details
NDC Product Code
70710-1756Application Number
ANDA215440Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 6, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ErythromycinActive
Code: 63937KV33DClass: ACTIBQuantity: 500 mg in 1 1
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7FClass: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT