DailyMed - TOFACITINIB tablet, film coated, extended release

NDC Code(s): 70771-1627-3, 70771-1627-9, 70771-1628-3, 70771-1628-9
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 27, 2023

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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 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

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INGREDIENTS AND APPEARANCE

Product Information

TOFACITINIB tofacitinib tablet, film coated, extended release

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

TOFACITINIB tofacitinib tablet, film coated, extended release

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Zydus Lifesciences Limited (918596198)

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

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	RxCUI	RxNorm NAME	RxTTY
1	1741046	tofacitinib 11 MG 24HR Extended Release Oral Tablet	PSN
2	1741046	24 HR tofacitinib 11 MG Extended Release Oral Tablet	SCD
3	1741046	tofacitinib 11 MG 24 HR Extended Release Oral Tablet	SY
4	1741046	tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet	SY
5	2273113	tofacitinib 22 MG 24HR Extended Release Oral Tablet	PSN
6	2273113	24 HR tofacitinib 22 MG Extended Release Oral Tablet	SCD

Label: TOFACITINIB tablet, film coated, extended release

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	NDC
1	70771-1627-3
2	70771-1627-9
3	70771-1628-3
4	70771-1628-9

Label: TOFACITINIB tablet, film coated, extended release

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TOFACITINIB tablet, film coated, extended release

Number of versions: 1

TOFACITINIB tablet, film coated, extended release

TOFACITINIB tablet, film coated, extended release

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TOFACITINIB tablet, film coated, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.