ITRACONAZOLE- itraconazole capsule 
Zydus Lifesciences Limited

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Itraconazole Capsules, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Itraconazole Capsules, 100 mg

NDC 70771-1208-3

30 Capsules

Itraconazole Capsules
ITRACONAZOLE 
itraconazole capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1208
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ITRACONAZOLE (UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4) ITRACONAZOLE100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
Product Characteristics
ColorBLUE (BLUE) Scoreno score
ShapeCAPSULE (CAPSULE) Size23mm
FlavorImprint Code ZA;65;100;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1208-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/06/201803/25/2025
2NDC:70771-1208-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/06/201803/25/2025
3NDC:70771-1208-410 in 1 CARTON03/06/201803/25/2025
3NDC:70771-1208-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:70771-1208-330 in 1 BOTTLE; Type 0: Not a Combination Product03/06/201803/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20467203/06/201805/30/2025
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1208) , MANUFACTURE(70771-1208)

Revised: 5/2025
Document Id: 3f77e072-5b8f-488d-82a4-4461c3a75e0f
Set id: a545b2bd-ef19-4d0d-b7f6-c695173eaa3c
Version: 7
Effective Time: 20250530
 
Zydus Lifesciences Limited