ERYTHROMYCIN- erythromycin tablet, film coated 
Zydus Lifesciences Limited

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Erytrhomycin Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1548-1 in bottle of 100 tablets

Erythromycin Tablets USP, 250 mg

Rx only

100 tablets

250 mg label

NDC 70771-1549-1 in bottle of 100 tablets

Erythromycin Tablets USP, 500 mg

Rx only

100 tablets

500 mg label
ERYTHROMYCIN 
erythromycin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1548
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
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)  
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) Scoreno score
ShapeOVAL (oval) Size15mm
FlavorImprint Code llll
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1548-330 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2023
2NDC:70771-1548-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2023
3NDC:70771-1548-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21269306/30/2023
ERYTHROMYCIN 
erythromycin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1549
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
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)  
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) Scoreno score
ShapeOVAL (oval) Size19mm
FlavorImprint Code 1048
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1549-330 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2023
2NDC:70771-1549-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2023
3NDC:70771-1549-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21269306/30/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1548, 70771-1549) , MANUFACTURE(70771-1548, 70771-1549)

Revised: 6/2023
Document Id: 35a32479-429b-4e71-9c5c-1e8ddbdff5e7
Set id: 76608fdd-1248-4942-9518-fd8076244fa7
Version: 2
Effective Time: 20230621
 
Zydus Lifesciences Limited