Home NDC 63539-016 XELJANZ
Product NDC 63539-016
11-digit product format 635390016
Labeler code 63539
Product ID 63539-016_3874b975-cdc0-46fe-8b73-5e0346e3a178
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tofacitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler U.S. Pharmaceuticals
Application NDA203214
Marketing category NDA
Marketing start 2018-07-02
Substance TOFACITINIB CITRATE
Active strength 10 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203214-001 XELJANZ TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB RLD 2012-11-06 N203214-002 XELJANZ TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB RLD, RS 2018-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 N203214-001 RE41783*PED 2026-06-08 Pediatric extension N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 N203214-002 RE41783*PED 2026-06-08 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N203214-001 M-14 2028-02-21 N203214-001 PED 2028-08-21
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.
Product history page 1 of 3 · 88 observed 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 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL AB RLD 2012-11-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL AB RLD, RS 2018-05-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL AB RLD 2012-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL AB RLD, RS 2018-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL AB RLD 2012-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL AB RLD, RS 2018-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 4b0b4de00fa7…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 206 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203214-001 RE41783*PED 2026-06-08 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203214-002 RE41783*PED 2026-06-08 Pediatric extension c2088c7a36db…2026-09-14 22:38:34 2026-08 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203214-001 RE41783*PED 2026-06-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203214-002 RE41783*PED 2026-06-08 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203214-001 RE41783*PED 2026-06-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203214-002 RE41783*PED 2026-06-08 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203214-001 RE41783*PED 2026-06-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203214-002 RE41783*PED 2026-06-08 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203214-001 RE41783*PED 2026-06-08 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203214-002 RE41783*PED 2026-06-08 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203214-001 RE41783*PED 2026-06-08 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203214-002 RE41783*PED 2026-06-08 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203214-001 RE41783*PED 2026-06-08 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203214-002 RE41783*PED 2026-06-08 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 d06236e962d9…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 109 observed states.
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 XELJANZ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOFACITINIB CITRATE 10 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2021-08-14 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR/XELJANZ Oral Solution safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR/XELJANZ Oral Solution. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use XELJANZ ® (tofacitinib) Oral Solution Initial U.S. Approval: 2012 2021-08-14 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-08-14 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-08-14 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-08-14 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-08-14 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-08-14 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-07-23 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR/XELJANZ Oral Solution safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR/XELJANZ Oral Solution. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use XELJANZ ® (tofacitinib) Oral Solution Initial U.S. Approval: 2012 2021-07-23 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-07-23 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-07-23 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-07-23 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-07-23 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 2021-07-23 These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63539-016-02 XELJANZ 60 in 1 BOTTLE TABLET, FILM COATED 60 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOFACITINIB CITRATE ACTIVE INGREDIENT O1FF4DIV0D XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 TOFACITINIB ACTIVE MOIETY 87LA6FU830 XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-016 XELJANZ (TOFACITINIB) TABLET, FILM COATED XELJANZ XR (TOFACITINIB) TABLET, EXTENDED RELEASE [U.S. PHARMACEUTICALS] 13 Current NDC, Legacy NDC, 1 package rows 20250306_68e3d6b2-7838-4d2d-a417-09d919b43e13.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63539-016-02 63539001602 60 TABLET, FILM COATED in 1 BOTTLE (63539-016-02) 2018-07-02 0000-00-00 No No Current