FDA.reportPublic FDA data

Signifor

Product NDC
55292-131
11-digit product format
552920131
Labeler code
55292
Product ID
55292-131_19a67a21-b599-41d1-9a7c-a5d31972d885
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pasireotide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Recordati Rare Diseases, Inc.
Application
NDA200677
Marketing category
NDA
Marketing start
2012-12-14
Substance
PASIREOTIDE
Active strength
.3 mg/mL
Pharmacologic classes
Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Signifor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PASIREOTIDE.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98H1T17066
Rxcui1364109, 1364114, 1364116, 1364118, 1364120, 1364122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
093f5f72-95bf-45e6-8f9d-fb29c1364d06Product name220180817

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55292-131-01Signifor1 mL in 1 AMPULEINJECTION120
55292-131-06Signifor6 in 1 PACKAGEINJECTION620
55292-131-60Signifor60 in 1 BOXINJECTION6020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55292-131-60ML - Milliliter55292-1313280d645-0e59-4e6b-9114-e9984573a61f12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55292-131SIGNIFOR (PASIREOTIDE) INJECTION [RECORDATI RARE DISEASES, INC.]17Current NDC, Legacy NDC, 3 package rows20250412_a09a25fc-a5a3-0c82-e053-2995a90a5d74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364109pasireotide 0.3 MG in 1 ML InjectionPSNa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364116pasireotide 0.6 MG in 1 ML InjectionPSNa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364120pasireotide 0.9 MG in 1 ML InjectionPSNa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364114Signifor 0.3 MG in 1 ML InjectionPSNa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364118Signifor 0.6 MG in 1 ML InjectionPSNa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364122Signifor 0.9 MG in 1 ML InjectionPSNa09a25fc-a5a3-0c82-e053-2995a90a5d7420
13641141 ML pasireotide 0.3 MG/ML Injection [Signifor]SBDa09a25fc-a5a3-0c82-e053-2995a90a5d7420
13641181 ML pasireotide 0.6 MG/ML Injection [Signifor]SBDa09a25fc-a5a3-0c82-e053-2995a90a5d7420
13641221 ML pasireotide 0.9 MG/ML Injection [Signifor]SBDa09a25fc-a5a3-0c82-e053-2995a90a5d7420
13641091 ML pasireotide 0.3 MG/ML InjectionSCDa09a25fc-a5a3-0c82-e053-2995a90a5d7420
13641161 ML pasireotide 0.6 MG/ML InjectionSCDa09a25fc-a5a3-0c82-e053-2995a90a5d7420
13641201 ML pasireotide 0.9 MG/ML InjectionSCDa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364109pasireotide (as pasireotide diaspartate) 0.3 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364116pasireotide (as pasireotide diaspartate) 0.6 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364120pasireotide (as pasireotide diaspartate) 0.9 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364109pasireotide 0.3 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364116pasireotide 0.6 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364120pasireotide 0.9 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364114Signifor (as pasireotide diaspartate) 0.3 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364118Signifor (as pasireotide diaspartate) 0.6 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364122Signifor (as pasireotide diaspartate) 0.9 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364114Signifor 0.3 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364118Signifor 0.6 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420
1364122Signifor 0.9 MG per 1 ML InjectionSYa09a25fc-a5a3-0c82-e053-2995a90a5d7420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55292-131-01552920131011 mL in 1 AMPULE1 mlHistorical
55292-131-06552920131066 in 1 PACKAGEHistorical
55292-131-605529201316060 PACKAGE in 1 BOX (55292-131-60) / 6 AMPULE in 1 PACKAGE (55292-131-06) / 1 mL in 1 AMPULE (55292-131-01) 60 package2012-12-140000-00-00NoNoCurrent