E.E.S
E.E.S. (ERYTHROMYCIN ETHYLSUCCINATE)
Approved
Approval ID
b455bbdb-a3f1-470f-aa5f-ed83ac2e228d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2023
Manufacturers
FDA
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
DUNS: 117505635
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythromycin Ethylsuccinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-134
Application NumberNDA050207
Product Classification
M
Marketing Category
C73594
G
Generic Name
Erythromycin Ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2023
FDA Product Classification
INGREDIENTS (7)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 200 mg in 5 mL
Code: 1014KSJ86F
Classification: ACTIM
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
Erythromycin Ethylsuccinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-136
Application NumberNDA050207
Product Classification
M
Marketing Category
C73594
G
Generic Name
Erythromycin Ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2023
FDA Product Classification
INGREDIENTS (7)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 200 mg in 5 mL
Code: 1014KSJ86F
Classification: ACTIM
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Erythromycin Ethylsuccinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-100
Application NumberANDA061905
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin Ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2023
FDA Product Classification
INGREDIENTS (14)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 400 mg in 1 1
Code: 1014KSJ86F
Classification: ACTIM