Home NDC 0069-0502 XELJANZ
Product NDC 0069-0502
11-digit product format 000690502
Labeler code 0069
Product ID 0069-0502_39aa36a4-7b51-43af-9bf0-d812b3f9bd1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tofacitinib
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA208246
Marketing category NDA
Marketing start 2020-01-21
Substance TOFACITINIB CITRATE
Active strength 22 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 N208246-001 XELJANZ XR TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2016-02-23 N208246-002 XELJANZ XR TOFACITINIB CITRATE EQ 22MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2019-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208246-001 RE41783 2025-12-08 Drug substance 2016-03-18 N208246-001 RE41783*PED 2026-06-08 Pediatric extension N208246-001 11253523 2034-03-14 U-3326 2022-03-23 N208246-001 11253523 2034-03-14 U-3327 2022-03-23 N208246-001 11253523 2034-03-14 U-3328 2022-03-23 N208246-001 11253523 2034-03-14 U-3329 2022-03-23 N208246-001 9937181 2034-03-14 Drug product 2018-05-09 N208246-001 11253523*PED 2034-09-14 Pediatric extension N208246-001 9937181*PED 2034-09-14 Pediatric extension N208246-002 RE41783 2025-12-08 Drug substance 2020-01-09 N208246-002 RE41783*PED 2026-06-08 Pediatric extension N208246-002 10639309 2034-03-14 Drug product 2020-06-03 N208246-002 11253523 2034-03-14 U-3326 2022-03-23 N208246-002 11253523 2034-03-14 U-3327 2022-03-23 N208246-002 11253523 2034-03-14 U-3328 2022-03-23 N208246-002 11253523 2034-03-14 U-3329 2022-03-23 N208246-002 10639309*PED 2034-09-14 Pediatric extension N208246-002 11253523*PED 2034-09-14 Pediatric extension
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 2026-08-01 22:54:32 2026-06 N208246-001 XELJANZ XR EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2016-02-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 XELJANZ XR EQ 22MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2019-12-12 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N208246-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N208246-001 RE41783 2025-12-08 Drug substance 2016-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-001 RE41783*PED 2026-06-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-001 11253523 2034-03-14 U-3326 2022-03-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-001 11253523 2034-03-14 U-3327 2022-03-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-001 11253523 2034-03-14 U-3328 2022-03-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-001 11253523 2034-03-14 U-3329 2022-03-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-001 9937181 2034-03-14 Drug product 2018-05-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-001 11253523*PED 2034-09-14 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-001 9937181*PED 2034-09-14 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 RE41783 2025-12-08 Drug substance 2020-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 RE41783*PED 2026-06-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 10639309 2034-03-14 Drug product 2020-06-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 11253523 2034-03-14 U-3326 2022-03-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 11253523 2034-03-14 U-3327 2022-03-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 11253523 2034-03-14 U-3328 2022-03-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 11253523 2034-03-14 U-3329 2022-03-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 10639309*PED 2034-09-14 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208246-002 11253523*PED 2034-09-14 Pediatric extension a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base XELJANZ
Brand name suffix XR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOFACITINIB CITRATE 22 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 0069-0502-30 XELJANZXR 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 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 0069-0502 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
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 0069-0502-30 00069050230 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0502-30) 2020-01-21 0000-00-00 No No Current