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#

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 4 of 127 · 2,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
TOFACITINIBTOFACITINIBSun Pharmaceutical Industries, Inc.a764a133-b870-4514-bbee-24d43f8cb7fd2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2478433
unii: O1FF4DIV0D
Polyethylene Glycol 3350INSTALAX POLYETHYLENE GLYCOL 3350Sun Pharmaceutical Industries, Inc.40bd1be7-de67-8dff-e063-6294a90aca952026-07-24WarningsExact identifier
unii: G2M7P15E5P
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33X04XA5AT
TofacitinibTOFACITINIBAvKARE5751321a-c904-44ae-e063-6394a90a26542026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2048566
rxcui: 1357541
unii: O1FF4DIV0D
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
TOFACITINIB CITRATETOFACITINIB CITRATERadha Pharmaceuticals, Inc.141ab3eb-982b-4242-89db-6ddce5be0c402026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
unii: O1FF4DIV0D
TOFACITINIB CITRATETOFACITINIB CITRATEScieGen Pharmaceuticals, INC.11d08738-efa3-4474-8eda-812bc04adfbb2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
unii: O1FF4DIV0D
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
TOFACITINIBTOFACITINIBAurobindo Pharma Limitede54b186f-e42a-4477-939c-8dd331045fbe2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
unii: O1FF4DIV0D
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
TOFACITINIBTOFACITINIBAurobindo Pharma Limited50962b08-99dd-ae73-e063-6394a90ad1eb2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2048566
rxcui: 1357541
unii: O1FF4DIV0D

Reported adverse events (FAERS/openFDA)#

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