Home NDC 70377-057 Tofacitinib
Product NDC 70377-057
11-digit product format 703770057
Labeler code 70377
Product ID 70377-057_93a2a5ce-b75f-77df-ec07-ccc1b238e0d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tofacitinib
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Biocon Pharma Inc
Application ANDA219442
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 44 .
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 A219442-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219442-001 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 2026-10-15 13:18:30 2026-09 A219442-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-11-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219442-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-11-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219442-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219442-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219442-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-11-17 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219442-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-11-17 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
Brand name suffix XR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOFACITINIB CITRATE 11 mg/1
DailyMed Product Concepts# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70377-057-11 70377005711 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70377-057-11) 2026-06-03 No No Current