FDA.reportPublic FDA data

NDC 65517-0002-01 - Adalimumab-ryvk

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
65517-0002
Requested NDC
65517-0002-01
Package NDCs from labels
65517-0002-1, 65517-0002-3, 65517-0002-2, 65517-0002-01
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2026-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Adalimumab-ryvk - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2026-03-03HUMAN PRESCRIPTION DRUG LABEL
Adalimumab-ryvk - Quallent Pharmaceuticals Health LLC | Alvotech HFQuallent Pharmaceuticals Health LLC | Alvotech HF2026-01-19HUMAN PRESCRIPTION DRUG LABEL
Adalimumab-ryvk - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2025-12-31HUMAN PRESCRIPTION DRUG LABEL
Simlandi - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2025-12-22HUMAN PRESCRIPTION DRUG LABEL
Simlandi - A-S Medication SolutionsA-S Medication Solutions2025-10-16HUMAN PRESCRIPTION DRUG LABEL
Dukal Sterile Alcohol Prep Pad - Dukal LLCDukal LLC2025-04-23HUMAN OTC DRUG LABEL
First Aid Only Alcohol Antiseptic Wipe - Acme United CorporationAcme United Corporation2024-11-26HUMAN OTC DRUG LABEL
Dukal Sterile Alcohol Prep Pad - Dukal CorporationDukal Corporation2019-02-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.8 mL0.7 mL in 1mL24
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL24
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL24
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.8 mL0.7 mL in 1mL12
65517-0002-1Dukal Sterile Alcohol Prep Pad0.4 mL in 1 POUCHSWAB0.48
65517-0002-3Dukal Sterile Alcohol Prep Pad0.4 mL in 1 POUCHSWAB0.48
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL7
65517-0002-2Dukal Sterile Alcohol Prep Pad1 mL in 1 POUCHSWAB12
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL1
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL1
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-0002SIMLANDI (ADALIMUMAB-RYVK) KIT [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, Legacy NDC20250313_12f609c9-2088-bb05-e063-6394a90a9ecc.zip
65517-0002DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL LLC]8Current NDC, Legacy NDC, 2 package rows20250426_00b2c444-8601-4d8f-b6bb-91b864fd9041.zip
65517-0002ADALIMUMAB-RYVK KIT [QUALLENT PHARMACEUTICALS HEALTH LLC]6Current NDC, Legacy NDC20250326_dce1590f-9e47-4c4d-9437-cfb18b779a75.zip
65517-0002DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]2Current NDC, Legacy NDC, 1 package rows20190301_54586d75-a0a1-46aa-9cc9-631094320bff.zip
65517-0002ADALIMUMAB-RYVK KIT [TEVA PHARMACEUTICALS USA, INC.]1Current NDC, Legacy NDC20250523_2d19a877-1f5a-4731-800a-dddadc424080.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RDUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RDUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]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 6 of 182 · 3,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Olimpo AntibacterialBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.597e3b3e-51f0-5fcf-e063-6394a90ac2972026-08-20WarningsExact identifier
application number: M003
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Benzalkonium ChlorideBENZALKONIUM CHLORIDE TOWELETTESTrifecta Pharmaceuticals USA LLC59811e67-57f0-4db1-e063-6294a90a2ad82026-08-20WarningsExact identifier
application number: M003
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ZYMFENTRAINFLIXIMAB-DYYBCELLTRION USA Inc.93a193ab-9f96-4da6-aa7c-31212e81879a2026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Hydrogen PeroxideHYDROGEN PEROXIDEThe Kroger Co.52f6258f-4b4c-49f4-9bc7-40dc3918869d2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLThe Kroger Co.b127bba1-ce0b-4142-8b7d-f12f062b09382026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.cd3f8779-9e57-4b23-a029-7424d4d4ab2a2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.ca6c7f8a-d41a-4d77-817c-3dbdc40f890e2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
unii: ND2M416302
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
application number: M003
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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