FDA.reportPublic FDA data

NDC 0069-1029-01 - 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
0069-1029
Requested NDC
0069-1029-01
Package NDCs from labels
0069-1029-01, 0069-1029-02
Manufacturer
Pfizer Laboratories Div Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd
Effective date
2026-09-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XELJANZPfizer Laboratories Div Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd2026-09-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1029-01XELJANZ240 mL in 1 BOTTLESOLUTION24053
0069-1029-02XELJANZ1 in 1 CARTONSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-1029XELJANZ (TOFACITINIB) TABLET, FILM COATED XELJANZ XR (TOFACITINIB) TABLET, FILM COATED, EXTENDED RELEASE XELJANZ (TOFACITINIB) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]49Current NDC, Legacy NDC, 2 package rows20241222_cf74ba2f-afc5-4baa-8594-979c889a5831.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-1029-01ML - Milliliter0069-1029e8f5459b-9e04-49e2-9207-b8563b645f0a12021-03-02
0069-1029-02ML - Milliliter0069-1029ab3afb2e-c7a8-4c8c-b7d7-2c29d2947f5212021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOFACITINIB CITRATEACTIVE INGREDIENTO1FF4DIV0DXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
TOFACITINIBACTIVE MOIETY87LA6FU830XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
TRIACETININACTIVE INGREDIENTXHX3C3X673XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12

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 127 · 2,534 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.