Home NDC 59651-685 TOFACITINIB
Product NDC 59651-685
11-digit product format 596510685
Labeler code 59651
Product ID 59651-685_7ce3b2ea-31b1-4429-85c7-90ebf4034c8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOFACITINIB
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA218462
Marketing category ANDA
Marketing start 2026-05-14
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 1 .
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 2026-08-01 22:54:32 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 2026-08-01 22:54:32 2026-06 A218462-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-685-30 TOFACITINIB 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 7
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-685-30 59651068530 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-685-30) 2026-05-14 No No Current