FDA.reportPublic FDA data

Signifor LAR

Product NDC
55292-140
11-digit product format
552920140
Labeler code
55292
Product ID
55292-140_fb5687ef-6bbc-4ac4-899e-46c941f214c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pasireotide
Dosage form
KIT
Labeler
Recordati Rare Diseases, Inc.
Application
NDA203255
Marketing category
NDA
Marketing start
2014-12-15
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1597596, 1597599, 1597601, 1597603, 1597820, 1597822, 2049730, 2049732, 2049734, 2049736

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
093f5f72-95bf-45e6-8f9d-fb29c1364d06Product name220180817

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55292-140-012025-08-01C16284748780-13b156c62-2cf9-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use SIGNIFOR LAR safely and effectively. See full prescribing information for SIGNIFOR LAR. SIGNIFOR ® LAR (pasireotide) for injectable suspension, for intramuscular use Initial U.S. Approval: 2012
55292-140-012025-07-29C16284748780-13b156c62-2cf9-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use SIGNIFOR LAR safely and effectively. See full prescribing information for SIGNIFOR LAR. SIGNIFOR ® LAR (pasireotide) for injectable suspension, for intramuscular use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55292-135-01Signifor LAR6 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SUSPENSIO6 mL10 mg in 1mL17
55292-140-01Signifor LAR1 in 1 KITKIT117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55292-140-01EA - Each55292-140720571b3-7513-4493-ab7a-6341aa52916412020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55292-140SIGNIFOR LAR (PASIREOTIDE) KIT [RECORDATI RARE DISEASES, INC.]17Current NDC, Legacy NDC, 2 package rows20240719_a0aad470-3f38-af97-e053-2995a90a383a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049734pasireotide LAR 10 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
1597596pasireotide LAR 20 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
2049730pasireotide LAR 30 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
1597601pasireotide LAR 40 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
1597820pasireotide LAR 60 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
2049736Signifor LAR 10 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
1597599Signifor LAR 20 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
2049732Signifor LAR 30 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
1597603Signifor LAR 40 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
1597822Signifor LAR 60 MG InjectionPSNa0aad470-3f38-af97-e053-2995a90a383a17
2049736pasireotide 10 MG Injection [Signifor]SBDa0aad470-3f38-af97-e053-2995a90a383a17
1597599pasireotide 20 MG Injection [Signifor]SBDa0aad470-3f38-af97-e053-2995a90a383a17
2049732pasireotide 30 MG Injection [Signifor]SBDa0aad470-3f38-af97-e053-2995a90a383a17
1597603pasireotide 40 MG Injection [Signifor]SBDa0aad470-3f38-af97-e053-2995a90a383a17
1597822pasireotide 60 MG Injection [Signifor]SBDa0aad470-3f38-af97-e053-2995a90a383a17
2049734pasireotide 10 MG InjectionSCDa0aad470-3f38-af97-e053-2995a90a383a17
1597596pasireotide 20 MG InjectionSCDa0aad470-3f38-af97-e053-2995a90a383a17
2049730pasireotide 30 MG InjectionSCDa0aad470-3f38-af97-e053-2995a90a383a17
1597601pasireotide 40 MG InjectionSCDa0aad470-3f38-af97-e053-2995a90a383a17
1597820pasireotide 60 MG InjectionSCDa0aad470-3f38-af97-e053-2995a90a383a17
2049734pasireotide LAR (as pasireotide pamoate) 10 MG InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17
1597596pasireotide LAR (as pasireotide pamoate) 20 MG InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17
2049730pasireotide LAR (as pasireotide pamoate) 30 MG InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17
1597601pasireotide LAR (as pasireotide pamoate) 40 MG InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17
1597820pasireotide LAR (as pasireotide pamoate) 60 mg InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17
2049736Signifor LAR (as pasireotide pamoate) 10 MG InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17
1597599Signifor LAR (as pasireotide pamoate) 20 MG InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17
2049732Signifor LAR (as pasireotide pamoate) 30 MG InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17
1597603Signifor LAR (as pasireotide pamoate) 40 MG InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17
1597822Signifor LAR (as pasireotide pamoate) 60 MG InjectionSYa0aad470-3f38-af97-e053-2995a90a383a17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55292-135-01552920135016 mL in 1 VIAL, SINGLE-USE6 mlHistorical
55292-140-01552920140011 KIT in 1 KIT (55292-140-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-135-01) * 2 mL in 1 SYRINGE1 kit2014-12-150000-00-00NoNoCurrent