TOFACITINIB- tofacitinib tablet, film coated, extended release 
Zydus Lifesciences Limited

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TOFACITINIB Extended-Release Tablets

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tofacitinib extended-release tablets, 11 mg

NDC 70771-1627-3

30 Tablets

Rx only

11 mg

Tofacitinib extended-release tablets, 22 mg

NDC 70771-1628-3

30 Tablets

Rx only

22 mg
TOFACITINIB 
tofacitinib tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1627
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOFACITINIB CITRATE (UNII: O1FF4DIV0D) (TOFACITINIB - UNII:87LA6FU830) TOFACITINIB11 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (light pink to pink) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code 1353
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1627-330 in 1 BOTTLE; Type 0: Not a Combination Product03/12/202503/25/2025
2NDC:70771-1627-990 in 1 BOTTLE; Type 0: Not a Combination Product03/12/202503/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21426403/12/202505/14/2025
TOFACITINIB 
tofacitinib tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1628
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOFACITINIB CITRATE (UNII: O1FF4DIV0D) (TOFACITINIB - UNII:87LA6FU830) TOFACITINIB22 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code 1727
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1628-330 in 1 BOTTLE; Type 0: Not a Combination Product03/12/202503/25/2025
2NDC:70771-1628-990 in 1 BOTTLE; Type 0: Not a Combination Product03/12/202503/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21426403/12/202505/14/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1627, 70771-1628) , MANUFACTURE(70771-1627, 70771-1628)

Revised: 12/2024
Document Id: f27a6498-4b12-46cb-87dc-0ca51bed6b8a
Set id: ac0b26d5-1352-42ff-b5ea-3eb02d8508a4
Version: 4
Effective Time: 20241204
 
Zydus Lifesciences Limited