Home NDC 0009-7166 SOMAVERT
Product NDC 0009-7166
11-digit product format 000097166
Labeler code 0009
Product ID 0009-7166_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 Identifier FDA.report destination 403806 Internal RxNorm lookup 403807 Internal RxNorm lookup 403808 Internal RxNorm lookup 404457 Internal RxNorm lookup 404458 Internal RxNorm lookup 404459 Internal RxNorm lookup 1549323 Internal RxNorm lookup 1549452 Internal RxNorm lookup 1549454 Internal RxNorm lookup 1549456 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0009-5175-02 SOMAVERT 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 mL 10 mg in 1mL 13 0009-7166-01 SOMAVERT 1 in 1 CARTON KIT 1 13 0009-7166-30 SOMAVERT 30 in 1 CARTON KIT 30 13 0009-7166-30 SOMAVERT 1 in 1 KIT KIT 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-7166 SOMAVERT (PEGVISOMANT) KIT [PHARMACIA & UPJOHN COMPANY LLC] 11 Current NDC, Legacy NDC, 4 package rows 20240413_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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021106 Somavert pegvisomant 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0009-5175-02 00009517502 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 0009-7166-01 00009716601 1 KIT in 1 CARTON (0009-7166-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5175-02) * 1 mL in 1 SYRINGE (0009-5936-01) 1 kit 2016-10-01 0000-00-00 No No Current 0009-7166-30 00009716630 30 KIT in 1 CARTON (0009-7166-30) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5175-02) * 1 mL in 1 SYRINGE (0009-5936-01) 30 kit 2022-01-17 0000-00-00 No No Current