SOMAVERT

Product NDC
0009-7188
11-digit product format
000097188
Labeler code
0009
Product ID
0009-7188_36dc9264-0f75-4059-ac68-65fa4bfcdcc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegvisomant
Dosage form
KIT
Labeler
Pharmacia & Upjohn Company LLC
Application
BLA021106
Marketing category
BLA
Marketing start
2016-10-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui403806, 403807, 403808, 404457, 404458, 404459, 1549323, 1549452, 1549454, 1549456

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-5179-02SOMAVERT1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1 mL20 mg in 1mL13
0009-7188-01SOMAVERT1 in 1 CARTONKIT113
0009-7188-30SOMAVERT1 in 1 KITKIT113
0009-7188-30SOMAVERT30 in 1 CARTONKIT3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-7188-01EA - Each0009-71880593b95d-d00e-48b7-a1ef-4eb1ee52024012016-12-07
0009-7188-30EA - Each0009-7188c614080f-5ecc-41e3-8c21-6d150bc6fbbf12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-7188SOMAVERT (PEGVISOMANT) KIT [PHARMACIA & UPJOHN COMPANY LLC]11Current NDC, Legacy NDC, 4 package rows20240413_3cbb485b-6df1-49ce-8747-592b395b1988.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403806pegvisomant 10 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
403807pegvisomant 15 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
403808pegvisomant 20 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
1549323pegvisomant 25 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
1549452pegvisomant 30 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
404457Somavert 10 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
404458Somavert 15 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
404459Somavert 20 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
1549456Somavert 25 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
1549454Somavert 30 MG InjectionPSN3cbb485b-6df1-49ce-8747-592b395b198813
404457pegvisomant 10 MG Injection [Somavert]SBD3cbb485b-6df1-49ce-8747-592b395b198813
404458pegvisomant 15 MG Injection [Somavert]SBD3cbb485b-6df1-49ce-8747-592b395b198813
404459pegvisomant 20 MG Injection [Somavert]SBD3cbb485b-6df1-49ce-8747-592b395b198813
1549456pegvisomant 25 MG Injection [Somavert]SBD3cbb485b-6df1-49ce-8747-592b395b198813
1549454pegvisomant 30 MG Injection [Somavert]SBD3cbb485b-6df1-49ce-8747-592b395b198813
403806pegvisomant 10 MG InjectionSCD3cbb485b-6df1-49ce-8747-592b395b198813
403807pegvisomant 15 MG InjectionSCD3cbb485b-6df1-49ce-8747-592b395b198813
403808pegvisomant 20 MG InjectionSCD3cbb485b-6df1-49ce-8747-592b395b198813
1549323pegvisomant 25 MG InjectionSCD3cbb485b-6df1-49ce-8747-592b395b198813
1549452pegvisomant 30 MG InjectionSCD3cbb485b-6df1-49ce-8747-592b395b198813
404457Somavert 10 MG InjectionSY3cbb485b-6df1-49ce-8747-592b395b198813
404458Somavert 15 MG InjectionSY3cbb485b-6df1-49ce-8747-592b395b198813
404459Somavert 20 MG InjectionSY3cbb485b-6df1-49ce-8747-592b395b198813
1549456Somavert 25 MG InjectionSY3cbb485b-6df1-49ce-8747-592b395b198813
1549454Somavert 30 MG InjectionSY3cbb485b-6df1-49ce-8747-592b395b198813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-5179-02000095179021 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0009-7188-01000097188011 KIT in 1 CARTON (0009-7188-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5179-02) * 1 mL in 1 SYRINGE (0009-5936-01) 1 kit2016-10-010000-00-00NoNoCurrent
0009-7188-300000971883030 KIT in 1 CARTON (0009-7188-30) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5179-02) * 1 mL in 1 SYRINGE (0009-5936-01) 30 kit2022-01-170000-00-00NoNoCurrent