Home NDC 0069-1001-01 XELJANZ
Product NDC 0069-1001
Requested package NDC 0069-1001-01
11-digit product format 000691001
Labeler code 0069
Product ID 0069-1001_39aa36a4-7b51-43af-9bf0-d812b3f9bd1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tofacitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA203214
Marketing category NDA
Marketing start 2012-11-09
Substance TOFACITINIB CITRATE
Active strength 5 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 1 .
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 · 82 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 2026-02-19 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…2019-12-13 00:20 UTC 2019-12 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203214-001 XELJANZ EQ 5MG BASE TABLET / ORAL RLD 2012-11-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N203214-002 XELJANZ EQ 10MG BASE TABLET / ORAL RLD, RS 2018-05-30 782e0a99824c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203214-001 AB 1 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203214-001 AB 1 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203214-001 AB 1 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N203214-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N203214-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 194 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203214-001 6965027 2023-03-25 Drug substance 2012-11-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203214-001 RE41783 2025-12-08 Drug substance 2012-11-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203214-002 6965027 2023-03-25 Drug substance 2018-06-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203214-002 RE41783 2025-12-08 Drug substance 2018-06-28 5c6f7cd8ea54…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 103 observed states.
Additional Listing Data#
Finished product Yes
Brand name base XELJANZ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOFACITINIB CITRATE 5 mg/1
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 0069-1001-01 XELJANZ 60 in 1 BOTTLE TABLET, FILM COATED 60 53
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOFACITINIB CITRATE ACTIVE INGREDIENT O1FF4DIV0D XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12 TOFACITINIB ACTIVE MOIETY 87LA6FU830 XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-1001 XELJANZ (TOFACITINIB) TABLET, FILM COATED XELJANZ XR (TOFACITINIB) TABLET, FILM COATED, EXTENDED RELEASE XELJANZ (TOFACITINIB) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 49 Current NDC, Legacy NDC, 1 package rows 20241222_cf74ba2f-afc5-4baa-8594-979c889a5831.zip
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 Marketing start Marketing end Sample Exclude flag Status 0069-1001-01 00069100101 60 TABLET, FILM COATED in 1 BOTTLE (0069-1001-01) 2012-11-09 0000-00-00 No No Current