FDA.reportPublic FDA data

Simlandi

Product NDC
51759-386
11-digit product format
517590386
Labeler code
51759
Product ID
51759-386_90174eed-a6f4-4153-92a1-623aadbcdc24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-ryvk
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
BLA761299
Marketing category
BLA
Marketing start
2025-01-29
NDC exclude flag
No
Listing certified through
2026-12-31
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
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
ndc (product): 51759-386
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
Simlandi
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2677780Internal RxNorm lookup
2677787Internal RxNorm lookup
2688819Internal RxNorm lookup
2688823Internal RxNorm lookup
2688826Internal RxNorm lookup
2688827Internal RxNorm lookup
2688828Internal RxNorm lookup
2688829Internal RxNorm lookup
2706644Internal RxNorm lookup
2706645Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12f609c9-2088-bb05-e063-6394a90a9eccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51759-386-22Simlandi2 in 1 CARTONKIT224
51759-386-22Simlandi1 in 1 KITKIT124
51759-497-31Simlandi0.2 mL in 1 SYRINGEINJECTION, SOLUTION0.2 mL20 mg in 0.2mL24
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51759-386-22EA - Each51759-386770c886c-3e3a-4841-8bb5-78e20478c4b812025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51759-386SIMLANDI (ADALIMUMAB-RYVK) KIT [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, 4 package rows20250313_12f609c9-2088-bb05-e063-6394a90a9ecc.zip

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
2688819adalimumab-ryvk 20 MG in 0.2 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2677780adalimumab-ryvk 40 MG in 0.4 ML Auto-InjectorPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688826adalimumab-ryvk 40 MG in 0.4 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2706644adalimumab-ryvk 80 MG in 0.8 ML Auto-InjectorPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688828adalimumab-ryvk 80 MG in 0.8 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 70 % Medicated PadPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688823Simlandi 20 MG in 0.2 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2677787Simlandi 40 MG in 0.4 ML Auto-InjectorPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688827Simlandi 40 MG in 0.4 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2706645Simlandi 80 MG in 0.8 ML Auto-InjectorPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688829Simlandi 80 MG in 0.8 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
26888230.2 ML adalimumab-ryvk 100 MG/ML Prefilled Syringe [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
26777870.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888270.4 ML adalimumab-ryvk 100 MG/ML Prefilled Syringe [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
27066450.8 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888290.8 ML adalimumab-ryvk 100 MG/ML Prefilled Syringe [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888190.2 ML adalimumab-ryvk 100 MG/ML Prefilled SyringeSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
26777800.4 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888260.4 ML adalimumab-ryvk 100 MG/ML Prefilled SyringeSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
27066440.8 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888280.8 ML adalimumab-ryvk 100 MG/ML Prefilled SyringeSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
27066450.8 ML Simlandi 100 MG/ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688819adalimumab-ryvk 20 MG per 0.2 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2677780adalimumab-ryvk 40 MG per 0.4 ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688826adalimumab-ryvk 40 MG per 0.4 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2706644adalimumab-ryvk 80 MG per 0.8 ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688828adalimumab-ryvk 80 MG per 0.8 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 70 % Medicated PadSY12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 70 % Topical ClothSY12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 70 % Topical SwabSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688823Simlandi 20 MG per 0.2 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2677787Simlandi 40 MG per 0.4 ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688827Simlandi 40 MG per 0.4 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2706645Simlandi 80 MG per 0.8 ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688829Simlandi 80 MG per 0.8 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51759-386-22517590386222 KIT in 1 CARTON (51759-386-22) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .2 mL in 1 SYRINGE (51759-497-31) * .4 mL in 1 POUCH (65517-0002-1) 2 kit2025-01-29NoNoCurrent
51759-497-31517590497310.2 mL in 1 SYRINGE0.2 mlHistorical
65517-0002-1655170002010.4 mL in 1 POUCH0.4 mlHistorical