FDA.reportPublic FDA data

Adalimumab-ryvk

Product NDC
51759-310
11-digit product format
517590310
Labeler code
51759
Product ID
51759-310_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

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
51759-310-59Adalimumab-ryvk1 in 1 KITKIT11
51759-310-59Adalimumab-ryvk2 in 1 CARTONKIT21
51759-312-30Adalimumab-ryvk0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL1
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL1

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 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): 51759-310
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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761299Simlandiadalimumab-ryvk351(k) InterchangeableRx2026-07-01

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
51759-310-59517590310592 KIT in 1 CARTON (51759-310-59) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE (51759-312-30) * .4 mL in 1 POUCH (65517-0002-1) 2 kit2026-05-01NoNoCurrent
51759-312-30517590312300.4 mL in 1 SYRINGE0.4 mlHistorical
65517-0002-1655170002010.4 mL in 1 POUCH0.4 mlHistorical