Home NDC 72162-2684 TOFACITINIB
Product NDC 72162-2684
11-digit product format 721622684
Labeler code 72162
Product ID 72162-2684_8d08684d-e488-4426-b2df-10addb5abf2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOFACITINIB
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA218462
Marketing category ANDA
Marketing start 2026-06-03
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 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 2026-09-14 22:38:34 2026-08 A218462-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-03 84e616aacf4f…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 2026-09-14 22:38:34 2026-08 A218462-001 AB 1 84e616aacf4f…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…
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
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 Aurobindo Pharma Limited e54b186f-e42a-4477-939c-8dd331045fbe 2026-07-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218462 application number: ANDA218462
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72162-2684-3 72162268403 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2684-3) 2026-10-02 No No Current