Home NDC 76333-111 TOFACITINIB
Product NDC 76333-111
11-digit product format 763330111
Labeler code 76333
Product ID 76333-111_5617ad3d-8470-c017-e063-6294a90a1b80
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOFACITINIB
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Orient Pharma Co., Ltd. Yunlin Plant
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219830-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219830-001 AB
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 2026-09-14 22:38:34 2026-08 A219830-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219830-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-06-09 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219830-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-06-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219830-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219830-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219830-001 AB 1 a50c72e98297…
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 11 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O1FF4DIV0D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1741046 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 76333-111-15 76333011115 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (76333-111-15) 2026-06-10 No No Current