Home NDC 42799-970 Tofacitinib
Product NDC 42799-970
11-digit product format 427990970
Labeler code 42799
Product ID 42799-970_9160be6c-f78e-4f91-be7f-ab89ae9acac9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tofacitinib
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Edenbridge Pharmaceuticals LLC.
Application ANDA218668
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 A218668-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218668-001 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 A218668-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218668-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218668-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218668-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218668-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL 2024-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218668-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218668-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218668-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-12-16 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218668-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-12-16 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 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# 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 Exclude flag Status 42799-970-30 42799097030 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42799-970-30) 2026-06-03 No No Current