FDA.reportPublic FDA data

NDC 82009-159 - 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
82009-159
Package NDCs from labels
82009-159-11
Manufacturer
Quallent Pharmaceuticals Health LLC | Alvotech HF
Effective date
2026-01-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Adalimumab-ryvk - Quallent Pharmaceuticals Health LLC | Alvotech HFQuallent Pharmaceuticals Health LLC | Alvotech HF2026-01-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82009-159-11Adalimumab-ryvk0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL12
82009-159-11Adalimumab-ryvk1 in 1 TRAYINJECTION, SOLUTION40 mg in 0.4mL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-159ADALIMUMAB-RYVK KIT [QUALLENT PHARMACEUTICALS HEALTH LLC]6Unmatched20250326_dce1590f-9e47-4c4d-9437-cfb18b779a75.zip

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 163 of 177 · 3,526 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep Pad Large PadISOPROPYL ALCOHOLHenry Schein Inc.b468eefd-625b-5c27-e053-2995a90ab0f42023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X
HADLIMAADALIMUMAB-BWWDA-S Medication Solutions7345f276-102e-4175-b7ef-ff1706b054722023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
Aqua marinaSODIUM CHLORIDEBoiron6a212a52-32be-21b8-e053-2991aa0aea2f2023-10-22Exact identifier
unii: 451W47IQ8X
Povidone Iodine Topical Solution PaintPOVIDONE IODINE 10%Jianerkang Medical Co., Ltdf231a572-a99d-4146-afa3-e73ea1cee0272023-10-22WarningsExact identifier
application number: M003
Povidone Iodine Topical Solution PaintPOVIDONE IODINE 10%Jianerkang Medical Co., Ltd42778607-6170-4a5e-94d0-5e6cd064eec62023-10-22WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd76048b01-28f3-4e43-9da9-974b2b511a102023-10-22WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
GENUINE FIRST AID Antiseptic Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.d25f02f1-268c-44d8-9a55-c6efcbe8eed12023-10-19WarningsExact identifier
application number: M003
Brompton and Langley Moisturizing Hand Sanitizer Lavnder VanillaALCOHOLGanzhou Olivee Cosmetic Co., Ltd.90bd3436-a8bc-4c19-a300-d59236a8de272023-10-19WarningsExact identifier
application number: M003
Up and Up 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTarget Corporationbecc8fe3-eaf5-4429-b462-a87dd09c4db82023-10-17WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Prevantics SwabCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.ff999b50-0b6b-404e-b4f1-c6694fe47a9b2023-10-13WarningsExact identifier
unii: ND2M416302
Prevantics SwabCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.db61e7fd-c421-4e3c-bc88-0343230273de2023-10-13WarningsExact identifier
unii: ND2M416302
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.766ad4df-2100-4f26-bd8b-5c5a0918698e2023-10-13WarningsExact identifier
application number: M003
GoodSense Alcohol SwabsISOPROPYL ALCOHOLGeiss, Destin and Dunn968bab9f-5b74-270b-e053-2995a90a0df42023-10-13WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.5854f241-6cfc-4e5a-ba72-92dd0703f7282023-10-13WarningsExact identifier
application number: M003
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
application number: M003
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
application number: M003
unii: ND2M416302
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDEAcme United Corporation07245b54-b193-178e-e063-6394a90a25812023-10-09WarningsExact identifier
application number: M003
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 451W47IQ8X
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLRejoice International Corp.06dc1730-216a-8b4d-e063-6294a90a41842023-10-04WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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