Home NDC 72865-367 Tofacitinib
Product NDC 72865-367
11-digit product format 728650367
Labeler code 72865
Product ID 72865-367_10403307-e2f9-44d1-bc72-552fdba299d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tofacitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler XLCare Pharmaceuticals Inc
Application ANDA219530
Marketing category ANDA
Marketing start 2026-10-09
Substance TOFACITINIB CITRATE
Active strength 10 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 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219530-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2026-06-03 A219530-002 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A219530-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2026-06-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219530-002 TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219530-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2026-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219530-002 TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219530-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2026-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219530-002 TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-03 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219530-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2026-06-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219530-002 TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 Ingredient Strength TOFACITINIB CITRATE 10 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tofacitinib TOFACITINIB Macleods Pharmaceuticals Limited 9b654f0d-7705-4880-9e9d-ad3a51e56b56 2026-08-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219530 application number: ANDA219530
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72865-367-12 72865036712 120 TABLET, FILM COATED in 1 BOTTLE (72865-367-12) 2026-10-09 No No Current 72865-367-60 72865036760 60 TABLET, FILM COATED in 1 BOTTLE (72865-367-60) 2026-10-09 No No Current