FDA.reportPublic FDA data

SOMAVERT

Product NDC
0009-7200
Requested package NDC
0009-7200-01
11-digit product format
000097200
Labeler code
0009
Product ID
0009-7200_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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403806Internal RxNorm lookup
403807Internal RxNorm lookup
403808Internal RxNorm lookup
404457Internal RxNorm lookup
404458Internal RxNorm lookup
404459Internal RxNorm lookup
1549323Internal RxNorm lookup
1549452Internal RxNorm lookup
1549454Internal RxNorm lookup
1549456Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3cbb485b-6df1-49ce-8747-592b395b1988Available on FDA.report

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
0009-5376-04SOMAVERT1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1 mL30 mg in 1mL13
0009-7200-01SOMAVERT1 in 1 CARTONKIT113
0009-7200-30SOMAVERT30 in 1 CARTONKIT3013
0009-7200-30SOMAVERT1 in 1 KITKIT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-7200-01EA - Each0009-7200e1702490-cb30-46d2-87f3-230eef810eb912016-12-07
0009-7200-30EA - Each0009-7200c1275613-6646-4029-8fac-f67d62d2af7a12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-7200SOMAVERT (PEGVISOMANT) KIT [PHARMACIA & UPJOHN COMPANY LLC]11Current NDC, Legacy NDC, 4 package rows20240413_3cbb485b-6df1-49ce-8747-592b395b1988.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOMAVERTPEGVISOMANTPharmacia & Upjohn Company LLC3cbb485b-6df1-49ce-8747-592b395b19882025-12-18Warnings, Adverse reactionsExact identifier
application number: BLA021106
ndc (package): 0009-7200-01
ndc (product): 0009-7200
ndc11 (package): 00009720001

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021106Somavertpegvisomant351(a)Rx2026-09-01

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
0009-7200-01000097200011 KIT in 1 CARTON (0009-7200-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5376-04) * 1 mL in 1 SYRINGE (0009-5936-01) 1 kit2016-10-010000-00-00NoNoCurrent