Home NDC 42571-268 TOFACITINIB
Product NDC 42571-268
11-digit product format 425710268
Labeler code 42571
Product ID 42571-268_5c4e0626-5f79-7e1f-e063-6294a90ad9cd
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 2026-06-03
Substance TOFACITINIB CITRATE
Active strength 5 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 · 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 2026-09-14 22:38:34 2026-08 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209738-002 TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209738-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209738-002 TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-03 caaa826d4ba7…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# 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 5 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42571-268-05 42571026805 500 TABLET, FILM COATED in 1 BOTTLE (42571-268-05) 2026-06-03 No No Current 42571-268-30 42571026830 30 TABLET, FILM COATED in 1 BOTTLE (42571-268-30) 2026-06-03 No No Current 42571-268-60 42571026860 60 TABLET, FILM COATED in 1 BOTTLE (42571-268-60) 2026-06-03 No No Current 42571-268-76 42571026876 150 BLISTER PACK in 1 CARTON (42571-268-76) / 15 TABLET, FILM COATED in 1 BLISTER PACK (42571-268-13) 150 blister pack 2026-06-03 No No Current