FDA.reportPublic FDA data

NDC 51759-368 - 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
51759-368
Package NDCs from labels
51759-368-21
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2025-12-31
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.2025-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51759-368-21Adalimumab-ryvk0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL7

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 53 of 179 · 3,564 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizing WipesALCOHOLGerms Be Gone LLC2bd6249b-f215-7aa9-e063-6394a90a65802026-01-20WarningsExact identifier
application number: M003
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
unii: 451W47IQ8X
SPA HAND SANITIZER SUMMER LEMONETHYL ALCOHOLRejoice International Corp.48dd563a-0558-cc76-e063-6294a90ab0412026-01-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48de4a31-c620-6c1c-e063-6394a90abb962026-01-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48df981a-74da-a629-e063-6294a90a7f402026-01-20WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker FreezeALCOHOLScent Theory Products LLC48c3d5e9-2d57-5a46-e063-6394a90a07222026-01-19WarningsExact identifier
application number: M003
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Adalimumab-ryvkADALIMUMAB-RYVKQuallent Pharmaceuticals Health LLCdce1590f-9e47-4c4d-9437-cfb18b779a752026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761299
ndc (package): 65517-0002-1
rxcui: 797544
rxcui: 2677780
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487b648a-1680-6de5-e063-6394a90ab8522026-01-16WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487e6851-1ca3-f9db-e063-6394a90a56f12026-01-16WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLSafetec of America, Inc.c3f0556d-f967-4f19-922c-57a2bf1848922026-01-16WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLSafetec of America3b5b46d0-308a-4649-8384-246da3a18ba12026-01-16WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLSafetec of Americabf69cc74-ebe9-40c3-a95a-a489492cc6932026-01-16WarningsExact identifier
application number: M003
NEXXGEN 50% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCd48232ab-ab55-488a-9cc1-77c8d0ba992e2026-01-16WarningsExact identifier
application number: M003
unii: ND2M416302
leuprolide acetateLEUPROLIDE ACETATEPAI Holdings, LLC dba PAI Pharma19be0b7f-e68a-4547-9e49-b51b128219072026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 797544
hi peach layneETHYL ALCOHOLZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD486ee2e0-2222-0574-e063-6294a90a9eff2026-01-15WarningsExact identifier
application number: M003
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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