AZITHROMYCIN- azithromycin tablet 
Zydus Lifesciences Limited

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Azithromycin Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Azithromycin Tablets USP, 250 mg

NDC 70771-1830-3

30 tablets

Rx only

250 mg label
AZITHROMYCIN 
azithromycin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1830
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) AZITHROMYCIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
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
ColorWHITE (off white) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 892
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1830-330 in 1 BOTTLE; Type 0: Not a Combination Product06/12/202507/25/2025
2NDC:70771-1830-83 in 1 CARTON06/12/202507/25/2025
2NDC:70771-1830-76 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21327506/12/202507/25/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1830) , MANUFACTURE(70771-1830)

Revised: 3/2025
Document Id: d8b0d0f3-9618-4b28-97b8-8917638c53b8
Set id: e963828e-0f92-40e7-996a-8cff95d328aa
Version: 3
Effective Time: 20250325
 
Zydus Lifesciences Limited