METHYLPREDNISOLONE - methylprednisolone tablet 
Zydus Lifesciences Limited

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Methylprednisolone Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1348-1 in bottle of 100 tablets

Methylprednisolone tablets, USP

Ronly

100 tablets

 

methylprednisolone tablets

NDC 70771-1349-8 in bottle of 25 tablets

Methylprednisolone tablets, USP

Ronly

25 tablets

 

 

methylprednisolone tablets

NDC 70771-1350-7 in bottle of 50 tablets

Methylprednisolone tablets, USP

Ronly

50 tablets

 

 

methylprednisolone tablets

NDC 70771-1351-8 in bottle of 25 tablets

Methylprednisolone tablets, USP

Ronly

25 tablets

 

 

 

 

methylprednisolone tablets
METHYLPREDNISOLONE 
methylprednisolone tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1348
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE4 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score4 pieces
ShapeOVAL (OVAL) Size8mm
FlavorImprint Code 916
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1348-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
2NDC:70771-1348-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
3NDC:70771-1348-31 in 1 CARTON05/01/2018
321 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675105/01/2018
METHYLPREDNISOLONE 
methylprednisolone tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1349
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE8 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size10mm
FlavorImprint Code 917
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1349-825 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
2NDC:70771-1349-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
3NDC:70771-1349-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
4NDC:70771-1349-410 in 1 CARTON05/01/2018
4NDC:70771-1349-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675105/01/2018
METHYLPREDNISOLONE 
methylprednisolone tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1350
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE16 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score4 pieces
ShapeOVAL (OVAL) Size10mm
FlavorImprint Code 918
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1350-750 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
2NDC:70771-1350-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
3NDC:70771-1350-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
4NDC:70771-1350-410 in 1 CARTON05/01/2018
4NDC:70771-1350-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675105/01/2018
METHYLPREDNISOLONE 
methylprednisolone tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1351
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE32 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size14mm
FlavorImprint Code 919
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1351-825 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
2NDC:70771-1351-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
3NDC:70771-1351-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
4NDC:70771-1351-410 in 1 CARTON05/01/2018
4NDC:70771-1351-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675105/01/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1348, 70771-1349, 70771-1350, 70771-1351) , MANUFACTURE(70771-1348, 70771-1349, 70771-1350, 70771-1351)

Revised: 10/2022
Document Id: 21e80f74-f0a4-4dc2-a415-b6b1bed285a7
Set id: fe9c15b5-4264-45f1-87b5-f7e1d6e6ddee
Version: 5
Effective Time: 20221031
 
Zydus Lifesciences Limited