FDA.reportPublic FDA data

Tofacitinib

Product NDC
72205-139
Requested package NDC
72205-139-60
11-digit product format
722050139
Labeler code
72205
Product ID
72205-139_253635c8-1ea7-41ba-b216-dea5e3305c47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tofacitinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA217299
Marketing category
ANDA
Marketing start
2026-06-03
Substance
TOFACITINIB CITRATE
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 1.

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
A217299-001TOFACITINIB CITRATETOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-03
A217299-002TOFACITINIB 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
A217299-001AB
A217299-002AB

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217299-001TOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217299-002TOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217299-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217299-002AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOFACITINIB CITRATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O1FF4DIV0DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1357541Internal RxNorm lookup
2048566Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
253635c8-1ea7-41ba-b216-dea5e3305c47Available on FDA.report

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
TofacitinibTOFACITINIBAvKARE5751321a-c904-44ae-e063-6394a90a26542026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217299
application number: ANDA217299
TofacitinibTOFACITINIBNovadoz Pharmaceuticals LLC253635c8-1ea7-41ba-b216-dea5e3305c472026-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217299
application number: ANDA217299
ndc (package): 72205-139-60
ndc (product): 72205-139
ndc11 (package): 72205013960

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
72205-139-607220501396060 TABLET, FILM COATED in 1 BOTTLE (72205-139-60)2026-06-030Current