Home NDC 0054-0821 tofacitinib solution
Product NDC 0054-0821
11-digit product format 000540821
Labeler code 0054
Product ID 0054-0821_b5f66dbf-b020-442e-bf19-4af33ac3c802
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tofacitinib
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA216878
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 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 A216878-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216878-001 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 2026-09-14 22:38:34 2026-08 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL 2023-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL 2023-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL 2023-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL 2023-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL 2023-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL 2023-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL 2023-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL 2023-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216878-001 TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA 2023-09-25 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 solution
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOFACITINIB CITRATE 1 mg/mL
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 2478433 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 Units Marketing start Sample Exclude flag Status 0054-0821-58 00054082158 1 BOTTLE in 1 CARTON (0054-0821-58) / 240 mL in 1 BOTTLE 1 bottle 2026-06-03 No No Current