ERYTHROMYCIN- erythromycin tablet, film coated 
Zydus Lifesciences Limited

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Erythromycin Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1732-3 in bottle of 30 tablets

Erythromycin Tablets USP, 250 mg

Rx only

30 tablets

250 mg

NDC 70771-1733-3 in bottle of 30 tablets

Erythromycin Tablets USP, 500 mg

Rx only

30 tablets

500 mg
ERYTHROMYCIN 
erythromycin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1732
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D) ERYTHROMYCIN250 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POVIDONE K30 (UNII: U725QWY32X)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
ColorPINK (peach to pink) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code 1755
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1732-330 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2023
2NDC:70771-1732-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2023
3NDC:70771-1732-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21544008/31/2023
ERYTHROMYCIN 
erythromycin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1733
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D) ERYTHROMYCIN500 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POVIDONE K30 (UNII: U725QWY32X)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
ColorPINK (light pink to pink) Scoreno score
ShapeOVALSize19mm
FlavorImprint Code 1756
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1733-330 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2023
2NDC:70771-1733-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2023
3NDC:70771-1733-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21544008/31/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1732, 70771-1733) , MANUFACTURE(70771-1732, 70771-1733)

Revised: 10/2023
Document Id: 069fde5e-64e7-4a55-9647-60565ce7f7a6
Set id: 866cf00e-f606-44fc-87a3-1798a63a48fe
Version: 1
Effective Time: 20231006
 
Zydus Lifesciences Limited