FDA.reportPublic FDA data

NDC 63539-029-01 - XELJANZ

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63539-029
Requested NDC
63539-029-01
Package NDCs from labels
63539-029-01, 63539-029-02
Manufacturer
U.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC
Effective date
2026-07-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XELJANZU.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC2026-07-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63539-029-01XELJANZ240 mL in 1 BOTTLESOLUTION24017
63539-029-02XELJANZ1 in 1 CARTONSOLUTION117

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOFACITINIB CITRATEACTIVE INGREDIENTO1FF4DIV0DXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
TOFACITINIBACTIVE MOIETY87LA6FU830XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
TRIACETININACTIVE INGREDIENTXHX3C3X673XELJANZ (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 129 · 2,565 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
unii: G2M7P15E5P
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
unii: G2M7P15E5P
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
TofacitinibTOFACITINIBNovadoz Pharmaceuticals LLC253635c8-1ea7-41ba-b216-dea5e3305c472026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2048566
rxcui: 1357541
unii: O1FF4DIV0D
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Mix-In Laxative PacketsPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc0347c934-1e85-4f8d-8d35-bb07f16810ad2026-08-27WarningsExact identifier
unii: G2M7P15E5P
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.