RISEDRONATE SODIUM- risedronate sodium tablet, delayed release 
Zydus Lifesciences Limited

----------

RISEDRONATE SODIUM DELAYED-RELEASE TABLETS

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1436-4 in blister-carton of 4 (1 x 4) Unit-dose Tablets

Risedronate Sodium Delayed-release Tablets, 35 mg

Rx only

4 Tablets

Risedronate Sodium DR Tablets, 35 mg
Risedronate Sodium DR Tablets, 35 mg
Risedronate Sodium DR Tablets, 35 mg
RISEDRONATE SODIUM 
risedronate sodium tablet, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1436
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISEDRONATE SODIUM ANHYDROUS (UNII: OFG5EXG60L) (RISEDRONIC ACID - UNII:KM2Z91756Z) RISEDRONATE SODIUM ANHYDROUS35 mg
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorYELLOW (YELLOW) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1436-41 in 1 CARTON04/10/2019
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20382204/10/2019
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1436) , MANUFACTURE(70771-1436)

Revised: 9/2023
Document Id: b096fdce-d4ce-4802-873e-2bf83ce54ac6
Set id: 37c8bed0-8cfe-445d-b506-bd89c8fae1a9
Version: 5
Effective Time: 20230927
 
Zydus Lifesciences Limited