Home NDC 63539-029 XELJANZ
Product NDC 63539-029
11-digit product format 635390029
Labeler code 63539
Product ID 63539-029_184c6caf-b874-4b42-9a0d-30219f3fd2ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tofacitinib
Dosage form SOLUTION
Route ORAL
Labeler U.S. Pharmaceuticals
Application NDA213082
Marketing category NDA
Marketing start 2021-02-08
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 42 .
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 N213082-001 XELJANZ TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N213082-001 AA
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 N213082-001 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 N213082-001 M-14 2028-02-21 N213082-001 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.
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 2026-08-18 06:07:40 2026-07 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213082-001 Xeljanz EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213082-001 Xeljanz EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213082-001 Xeljanz EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 50 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213082-001 RE41783*PED 2026-06-08 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213082-001 RE41783*PED 2026-06-08 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213082-001 RE41783*PED 2026-06-08 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213082-001 RE41783*PED 2026-06-08 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213082-001 RE41783*PED 2026-06-08 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213082-001 6956041 2020-12-08 Drug product 2020-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N213082-001 7265221 2020-12-08 Drug substance 2020-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N213082-001 7301023 2020-12-08 Drug substance 2020-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213082-001 6956041 2020-12-08 Drug product 2020-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N213082-001 7265221 2020-12-08 Drug substance 2020-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N213082-001 7301023 2020-12-08 Drug substance 2020-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 9b2671bbb829…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base XELJANZ
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 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1357541 Internal RxNorm lookup 1357547 Internal RxNorm lookup 1741046 Internal RxNorm lookup 1741049 Internal RxNorm lookup 2048566 Internal RxNorm lookup 2048568 Internal RxNorm lookup 2273113 Internal RxNorm lookup 2273115 Internal RxNorm lookup 2478433 Internal RxNorm lookup 2478437 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 63539-029-01 XELJANZ 240 mL in 1 BOTTLE SOLUTION 240 17 63539-029-02 XELJANZ 1 in 1 CARTON SOLUTION 1 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
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63539-029-01 63539002901 240 mL in 1 BOTTLE 240 ml Historical 63539-029-02 63539002902 1 BOTTLE in 1 CARTON (63539-029-02) / 240 mL in 1 BOTTLE (63539-029-01) 1 bottle 2021-02-08 No No Current