FDA.reportPublic FDA data

Tofacitinib

Product NDC
84677-054
Requested package NDC
84677-054-60
11-digit product format
846770054
Labeler code
84677
Product ID
84677-054_58f22511-eebf-fdbd-e063-6294a90adb8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tofacitinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Application
ANDA218096
Marketing category
ANDA
Marketing start
2026-06-01
Substance
TOFACITINIB
Active strength
5 mg/1
Pharmacologic classes
Janus Kinase Inhibitor [EPC]; Janus Kinase Inhibitors [MoA]
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218096-001TOFACITINIB CITRATETOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-03
A218096-002TOFACITINIB CITRATETOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A218096-001AB
A218096-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218096-001TOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07A218096-002TOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-03caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218096-001TOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218096-002TOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218096-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218096-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218096-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218096-002AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOFACITINIB5 mg/1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TofacitinibTOFACITINIBGolden State Medical Supply, Inc.58f22c41-87d2-e745-e063-6394a90a962e2026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218096
application number: ANDA218096
ndc (package): 84677-054-60
ndc (product): 84677-054
ndc11 (package): 84677005460
TofacitinibTOFACITINIBApotex Corp.7d4f5cfa-35a8-1458-a609-f6b417946abb2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218096
application number: ANDA218096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
84677-054-608467700546060 TABLET, FILM COATED in 1 BOTTLE (84677-054-60)2026-06-010Current