Erythromycin
ERYTHROMYCIN TABLETS, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin tablets and other antibacterial drugs, erythromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
fae8fc38-3c60-43b8-a0f9-2c50df332505
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Cadila Pharmaceuticals Limited
DUNS: 862257719
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-101
Application NumberANDA213628
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (18)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ERYTHROMYCINActive
Quantity: 500 mg in 1 1
Code: 63937KV33D
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
Erythromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-100
Application NumberANDA213628
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (18)
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
ERYTHROMYCINActive
Quantity: 250 mg in 1 1
Code: 63937KV33D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT