FDA.reportPublic FDA data

TOFACITINIB

Product NDC
59651-685
11-digit product format
596510685
Labeler code
59651
Product ID
59651-685_7ce3b2ea-31b1-4429-85c7-90ebf4034c8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOFACITINIB
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218462
Marketing category
ANDA
Marketing start
2026-05-14
Substance
TOFACITINIB CITRATE
Active strength
11 mg/1
Pharmacologic classes
Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TOFACITINIB
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOFACITINIB CITRATE11 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO1FF4DIV0D
Rxcui1741046

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10e4c2fb-ffa2-728d-14d9-1c6c2f2b27b6Product name420250623

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-685-30TOFACITINIB30 in 1 BOTTLETABLET, EXTENDED RELEASE307

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741046tofacitinib 11 MG 24HR Extended Release Oral TabletPSNe54b186f-e42a-4477-939c-8dd331045fbe7
174104624 HR tofacitinib 11 MG Extended Release Oral TabletSCDe54b186f-e42a-4477-939c-8dd331045fbe7
1741046tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSYe54b186f-e42a-4477-939c-8dd331045fbe7
1741046tofacitinib 11 MG 24 HR Extended Release Oral TabletSYe54b186f-e42a-4477-939c-8dd331045fbe7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-685-305965106853030 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-685-30) 2026-05-14NoNoCurrent