AZITHROMYCIN- azithromycin tablet 
Zydus Lifesciences Limited

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Azithromycin Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Azithromycin Tablets USP, 500 mg

NDC 70771-1829-3

30 tablets

Rx only

500 mg label
AZITHROMYCIN 
azithromycin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1829
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) AZITHROMYCIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorYELLOW (light yellow colored) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint Code 893
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1829-330 in 1 BOTTLE; Type 0: Not a Combination Product06/12/202507/25/2025
2NDC:70771-1829-83 in 1 CARTON06/12/202507/25/2025
2NDC:70771-1829-73 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21305606/12/202507/25/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1829) , MANUFACTURE(70771-1829)

Revised: 3/2025
Document Id: 840c9c79-1518-4e20-9f09-b5028784aa8f
Set id: f3f144a2-fb67-4c95-94ed-f772c39537b6
Version: 3
Effective Time: 20250325
 
Zydus Lifesciences Limited