TOFACITINIB Extended-Release Tablets

tofacitinib by

Drug Labeling and Warnings

tofacitinib by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Tofacitinib extended-release tablets, 22 mg

NDC: 70771-1628-3

30 Tablets

Rx only

TOFACITINIB 
tofacitinib tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1627
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOFACITINIB CITRATE (UNII: O1FF4DIV0D) (TOFACITINIB - UNII:87LA6FU830)	TOFACITINIB	11 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK (light pink to pink)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	1353
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1627-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2025	03/25/2025
2	NDC: 70771-1627-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2025	03/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214264	03/12/2025	05/14/2025

TOFACITINIB 
tofacitinib tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1628
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOFACITINIB CITRATE (UNII: O1FF4DIV0D) (TOFACITINIB - UNII:87LA6FU830)	TOFACITINIB	22 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (off-white)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	1727
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1628-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2025	03/25/2025
2	NDC: 70771-1628-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2025	03/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214264	03/12/2025	05/14/2025

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1627, 70771-1628) , MANUFACTURE(70771-1627, 70771-1628)

Revised: 12/2024

Document Id: f27a6498-4b12-46cb-87dc-0ca51bed6b8a

34391-3

Set id: ac0b26d5-1352-42ff-b5ea-3eb02d8508a4

Version: 4

Effective Time: 20241204