Home NDC 42571-377-05 TOFACITINIB
Product NDC 42571-377
Requested package NDC 42571-377-05
11-digit product format 425710377
Labeler code 42571
Product ID 42571-377_57e3cc57-9fe8-b19b-e063-6394a90aae90
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tofacitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Micro Labs Limited
Application ANDA209738
Marketing category ANDA
Marketing start 2026-06-08
Substance TOFACITINIB CITRATE
Active strength 10 mg/1
Pharmacologic classes Janus Kinase Inhibitor [EPC]; Janus Kinase Inhibitors [MoA]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A209738-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 A209738-002 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 2026-02-19 14:30 UTC 2026-02 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209738-002 TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-03 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209738-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209738-002 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 10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1357541 Internal RxNorm lookup 2048566 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 42571-377-05 42571037705 500 TABLET, FILM COATED in 1 BOTTLE (42571-377-05) 2026-06-08 0 Current