ROFLUMILAST- roflumilast tablet 
Zydus Lifesciences Limited

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Roflumilast Tablets, for oral use

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1674-3

Roflumilast Tablets, 500 mcg

30 tablets

Rx only

500 mcg label

NDC 70771-1673-8

Roflumilast Tablets, 250 mcg

Blister pack of 28 tablets

Rx only

250 mcg blister label
ROFLUMILAST 
roflumilast tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1674
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROFLUMILAST (UNII: 0P6C6ZOP5U) (ROFLUMILAST - UNII:0P6C6ZOP5U) ROFLUMILAST500 ug
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code T5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1674-330 in 1 BOTTLE; Type 0: Not a Combination Product10/03/2022
2NDC:70771-1674-990 in 1 BOTTLE; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20830310/03/2022
ROFLUMILAST 
roflumilast tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1673
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROFLUMILAST (UNII: 0P6C6ZOP5U) (ROFLUMILAST - UNII:0P6C6ZOP5U) ROFLUMILAST250 ug
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code T6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1673-81 in 1 CARTON05/18/2023
128 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70771-1673-32 in 1 CARTON05/18/2023
2NDC:70771-1673-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20830305/18/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1673, 70771-1674) , MANUFACTURE(70771-1673, 70771-1674)

Revised: 8/2024
Document Id: eb40db9e-ddc1-4041-aac5-ff0f2c478fc6
Set id: e87287bd-eae3-46c3-9072-04800aeabf40
Version: 4
Effective Time: 20240812
 
Zydus Lifesciences Limited