FDA.reportPublic FDA data

TOFACITINIB

Product NDC
76282-816
Requested package NDC
76282-816-30
11-digit product format
762820816
Labeler code
76282
Product ID
76282-816_877be72f-0a5f-4eaa-8986-0b4af3e447a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOFACITINIB
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Exelan pharmaceuticals,Inc
Application
ANDA219830
Marketing category
ANDA
Marketing start
2026-06-10
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219830-001TOFACITINIB CITRATETOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2026-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219830-001AB

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
2026-09-14 22:38:342026-08A219830-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2026-06-0984e616aacf4f…
2026-08-18 06:07:402026-07A219830-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2026-06-09caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219830-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2026-06-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219830-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A219830-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219830-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1741046Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e68680e5-0328-4e66-b8bb-4af126221ec7Available 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
TOFACITINIBTOFACITINIBOrient Pharma Co., Ltd. Yunlin Plant5617a652-a78e-74b1-e063-6394a90a31c72026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219830
application number: ANDA219830
TOFACITINIBTOFACITINIBExelan pharmaceuticals,Ince68680e5-0328-4e66-b8bb-4af126221ec72026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219830
application number: ANDA219830
ndc (package): 76282-816-30
ndc (product): 76282-816
ndc11 (package): 76282081630

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76282-816-307628208163030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (76282-816-30) 2026-06-10NoNoCurrent