ALBENDAZOLE - albendazole tablet, film coated 
Zydus Lifesciences Limited

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ALBENDAZOLE tablets, for oral use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1103-7

Albendazole Tablets USP, 200 mg

28 Tablets

Rx only

Albendazole tablets
ALBENDAZOLE 
albendazole tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBENDAZOLE (UNII: F4216019LN) (ALBENDAZOLE - UNII:F4216019LN) ALBENDAZOLE200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint Code 1021
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1103-728 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
2NDC:70771-1103-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
3NDC:70771-1103-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
4NDC:70771-1103-81 in 1 BOTTLE12/17/2018
42 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:70771-1103-62 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
6NDC:70771-1103-31 in 1 CARTON05/27/2020
62 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20897912/17/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1103) , MANUFACTURE(70771-1103)

Revised: 10/2022
Document Id: 4efbee3c-4848-451c-9744-c3eca20c1c16
Set id: 77f18744-318f-4588-8c3a-68fc1eb95eb0
Version: 4
Effective Time: 20221013
 
Zydus Lifesciences Limited