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 8 of 127 · 2,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
unii: 15FIX9V2JP
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350PIONEER LIFE SCIENCES, LLC478f104a-0e50-479c-8722-a3f1eab686912026-06-11WarningsExact identifier
unii: G2M7P15E5P
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
unii: 15FIX9V2JP
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP
365 WHOLE FOODS MARKET Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Whole Foods Market, Inc.b19f42a9-18ac-4d23-87b5-3c43e47c40542026-06-05WarningsExact identifier
unii: G2M7P15E5P
TofacitinibTOFACITINIBAjanta Pharma USA Inc.024bb9f2-8c26-4d9d-a33b-eb3c0a7c59ed2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
unii: O1FF4DIV0D
GAVILAXPOLYETHYLENE GLYCOL 3350Atlantic Biologicals Corp.4c207478-6f0f-c3cf-e063-6394a90aa4f22026-06-04WarningsExact identifier
unii: G2M7P15E5P
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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