FDA.reportPublic FDA data

Adalimumab-ryvk

Product NDC
51759-311
11-digit product format
517590311
Labeler code
51759
Product ID
51759-311_c109ab9f-879a-4e37-b6ff-10a027779522
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-ryvk
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
BLA761299
Marketing category
BLA
Marketing start
2026-05-01
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adalimumab-ryvkADALIMUMAB-RYVKTeva Pharmaceuticals USA, Inc.f8c0d3c2-b5ed-4bb8-927c-5c5529343ee62026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761299
ndc (product): 51759-311
Adalimumab-ryvkADALIMUMAB-RYVKQuallent Pharmaceuticals Health LLCdce1590f-9e47-4c4d-9437-cfb18b779a752026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761299
Adalimumab-ryvkADALIMUMAB-RYVKTeva Pharmaceuticals USA, Inc.2d19a877-1f5a-4731-800a-dddadc4240802025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761299
SimlandiADALIMUMAB-RYVKTeva Pharmaceuticals USA, Inc.12f609c9-2088-bb05-e063-6394a90a9ecc2025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761299
SimlandiADALIMUMAB-RYVKA-S Medication Solutionsba9dd71c-13c9-4cfe-84a2-b4f17d1c583f2025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761299

Additional Listing Data#

Finished product
Yes
Brand name base
Adalimumab-ryvk
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2677780Internal RxNorm lookup
2706644Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8c0d3c2-b5ed-4bb8-927c-5c5529343ee6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51759-311-58Adalimumab-ryvk1 in 1 CARTONKIT11
51759-311-58Adalimumab-ryvk1 in 1 KITKIT11
51759-313-30Adalimumab-ryvk0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.8 mL80 mg in 0.8mL1
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL1

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761299Simlandiadalimumab-ryvk351(k) InterchangeableRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677780adalimumab-ryvk 40 MG in 0.4 ML Auto-InjectorPSNf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
2706644adalimumab-ryvk 80 MG in 0.8 ML Auto-InjectorPSNf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
797544isopropyl alcohol 70 % Medicated PadPSNf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
26777800.4 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCDf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
27066440.8 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCDf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
2677780adalimumab-ryvk 40 MG per 0.4 ML Auto-InjectorSYf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
2706644adalimumab-ryvk 80 MG per 0.8 ML Auto-InjectorSYf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
797544isopropyl alcohol 70 % Medicated PadSYf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
797544isopropyl alcohol 70 % Topical ClothSYf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
797544isopropyl alcohol 70 % Topical SwabSYf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51759-311-58517590311581 KIT in 1 CARTON (51759-311-58) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (51759-313-30) * .4 mL in 1 POUCH (65517-0002-1) 1 kit2026-05-01NoNoCurrent
51759-313-30517590313300.8 mL in 1 SYRINGE0.8 mlHistorical
65517-0002-1655170002010.4 mL in 1 POUCH0.4 mlHistorical