FDA.reportPublic FDA data

Simlandi

Product NDC
51759-523
11-digit product format
517590523
Labeler code
51759
Product ID
51759-523_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

Additional Listing Data#

Finished product
Yes
Brand name base
Simlandi
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 2677780, 2677787, 2688819, 2688823, 2688826, 2688827, 2688828, 2688829, 2706644, 2706645

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
51759-523-21Simlandi1 in 1 KITKIT124
51759-523-21Simlandi1 in 1 CARTONKIT124
51759-634-31Simlandi0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.8 mL80 mg in 0.8mL24
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.8 mL0.7 mL in 1mL24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51759-523-21EA - Each51759-523f05aaecb-f373-4780-a759-f617bdfaf25d12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51759-523SIMLANDI (ADALIMUMAB-RYVK) KIT [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, 4 package rows20250313_12f609c9-2088-bb05-e063-6394a90a9ecc.zip

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
51759-523-21517590523211 KIT in 1 CARTON (51759-523-21) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (51759-634-31) * .4 mL in 1 POUCH (65517-0002-1) 1 kit2025-01-29NoNoHistorical
51759-634-31517590634310.8 mL in 1 SYRINGE0.8 mlHistorical
65517-0002-1655170002010.4 mL in 1 POUCH0.4 mlHistorical