Home NDC 70771-1821-8 tofacitinib
Product NDC 70771-1821
Requested package NDC 70771-1821-8
11-digit product format 707711821
Labeler code 70771
Product ID 70771-1821_81975bd4-d6d1-46b8-ba9f-eaad085435ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tofacitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA209829
Marketing category ANDA
Marketing start 2026-05-11
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70771-1821 70771-1821-8 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70771-1821 70771-1821-8 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A209829-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 A209829-002 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-05
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 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL 2023-03-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209829-001 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 A209829-002 TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209829-001 AB 1 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209829-001 AB 1 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209829-001 AB 1 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209829-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209829-002 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 5 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1821-6 tofacitinib 60 in 1 BOTTLE TABLET, FILM COATED 60 4 70771-1821-8 tofacitinib 180 in 1 BOTTLE TABLET, FILM COATED 180 4
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 70771-1821-8 70771182108 180 TABLET, FILM COATED in 1 BOTTLE (70771-1821-8) 2026-05-11 No No Current