FDA.reportPublic FDA data

TOFACITINIB CITRATE

Product NDC
85972-122
11-digit product format
859720122
Labeler code
85972
Product ID
85972-122_9d643ba7-2cb4-495a-b96d-3c1f2832442f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOFACITINIB CITRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Stellon Biotech Inc.
Application
ANDA218821
Marketing category
ANDA
Marketing start
2026-10-01
Substance
TOFACITINIB CITRATE
Active strength
16.16 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218821-001TOFACITINIB CITRATETOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-09
A218821-002TOFACITINIB CITRATETOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218821-001AB
A218821-002AB

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
2026-09-14 22:38:342026-08A218821-001TOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-0984e616aacf4f…
2026-09-14 22:38:342026-08A218821-002TOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-0984e616aacf4f…
2026-08-18 06:07:402026-07A218821-001TOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A218821-002TOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-09caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218821-001TOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218821-002TOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218821-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218821-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A218821-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218821-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218821-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218821-002AB1a50c72e98297…

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 CITRATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOFACITINIB CITRATE16.16 mg/1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85972-122-608597201226060 TABLET, FILM COATED in 1 BOTTLE (85972-122-60) 2026-10-01NoNoCurrent