Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals Private Limited
Amneal Pharmaceuticals NY LLC
650762060
Products3
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
69238-1471Application Number
ANDA210954Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 29, 2023ErythromycinActive
Code: 63937KV33DClass: ACTIBQuantity: 250 mg in 1 1
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKRClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
Erythromycin
Product Details
NDC Product Code
69238-1473Application Number
ANDA210954Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 29, 2023CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKRClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ErythromycinActive
Code: 63937KV33DClass: ACTIBQuantity: 500 mg in 1 1
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Erythromycin
Product Details
NDC Product Code
69238-1472Application Number
ANDA210954Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 29, 2023DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKRClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ErythromycinActive
Code: 63937KV33DClass: ACTIBQuantity: 333 mg in 1 1