Home NDC 70095-008 TOFACITINIB
Product NDC 70095-008
11-digit product format 700950008
Labeler code 70095
Product ID 70095-008_5df0c4de-6f68-64e3-e063-6294a90a5c20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tofacitinib
Dosage form SOLUTION
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA218407
Marketing category ANDA
Marketing start 2026-06-03
Substance TOFACITINIB CITRATE
Active strength 1 mg/mL
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 A218407-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2026-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218407-001 AA
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 A218407-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2026-06-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A218407-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2026-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218407-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2026-06-03 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218407-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 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 1 mg/mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70095-008-02 70095000802 1 BOTTLE in 1 CARTON (70095-008-02) / 240 mL in 1 BOTTLE 1 bottle 2026-06-03 No No Current