Home NDC 59651-685 TOFACITINIB
Product NDC 59651-685
11-digit product format 596510685
Labeler code 59651
Product ID 59651-685_7ce3b2ea-31b1-4429-85c7-90ebf4034c8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOFACITINIB
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA218462
Marketing category ANDA
Marketing start 2026-05-14
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 42 .
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 A218462-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218462-001 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 2026-08-18 06:07:40 2026-07 A218462-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218462-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218462-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218462-001 TOFACITINIB EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-03 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218462-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-03 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A218462-001 AB 1 caaa826d4ba7…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218462-001 AB 1 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218462-001 AB 1 a50c72e98297…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-685-30 TOFACITINIB 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 7
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-685-30 59651068530 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-685-30) 2026-05-14 No No Current