FDA.reportPublic FDA data

Adalimumab-ryvk

Product NDC
82009-156
11-digit product format
820090156
Labeler code
82009
Product ID
82009-156_e837767b-482a-487d-9d35-4516a8c25b3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-ryvk
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Quallent Pharmaceuticals Health LLC
Application
BLA761299
Marketing category
BLA
Marketing start
2024-05-22
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

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
2688826Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dce1590f-9e47-4c4d-9437-cfb18b779a75Available 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
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.8 mL0.7 mL in 1mL12
82009-156-22Adalimumab-ryvk2 in 1 CARTONKIT212
82009-156-22Adalimumab-ryvk1 in 1 KITKIT112
82009-157-11Adalimumab-ryvk1 in 1 TRAYINJECTION, SOLUTION40 mg in 0.4mL12
82009-157-11Adalimumab-ryvk0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-156-22EA - Each82009-1569035ec6b-9d46-474d-b17e-0f57ab031dc712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-156ADALIMUMAB-RYVK KIT [QUALLENT PHARMACEUTICALS HEALTH LLC]6Current NDC, 5 package rows20250326_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 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
Adalimumab-ryvkADALIMUMAB-RYVKQuallent Pharmaceuticals Health LLCdce1590f-9e47-4c4d-9437-cfb18b779a752026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761299
ndc (product): 82009-156
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) InterchangeableRx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677780adalimumab-ryvk 40 MG in 0.4 ML Auto-InjectorPSNdce1590f-9e47-4c4d-9437-cfb18b779a7512
2688826adalimumab-ryvk 40 MG in 0.4 ML Prefilled SyringePSNdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 70 % Medicated PadPSNdce1590f-9e47-4c4d-9437-cfb18b779a7512
26777800.4 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCDdce1590f-9e47-4c4d-9437-cfb18b779a7512
26888260.4 ML adalimumab-ryvk 100 MG/ML Prefilled SyringeSCDdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDdce1590f-9e47-4c4d-9437-cfb18b779a7512
2677780adalimumab-ryvk 40 MG per 0.4 ML Auto-InjectorSYdce1590f-9e47-4c4d-9437-cfb18b779a7512
2688826adalimumab-ryvk 40 MG per 0.4 ML Prefilled SyringeSYdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 70 % Medicated PadSYdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 70 % Topical ClothSYdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 70 % Topical SwabSYdce1590f-9e47-4c4d-9437-cfb18b779a7512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65517-0002-1655170002010.4 mL in 1 POUCH0.4 mlHistorical
82009-156-22820090156222 KIT in 1 CARTON (82009-156-22) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (82009-157-11) / .4 mL in 1 SYRINGE * .4 mL in 1 POUCH (65517-0002-1) 2 kit2024-05-22NoNoCurrent
82009-157-11820090157111 in 1 TRAYHistorical