FDA.reportPublic FDA data

NDC 0009-5201 - SOMAVERT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0009-5201
Package NDCs from labels
0009-5201-04
Manufacturer
Pharmacia & Upjohn Company LLC | Pfizer Manufacturing Belgium NV | Pfizer Ireland Pharmaceuticals Unlimited Company
Effective date
2025-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SOMAVERTPharmacia & Upjohn Company LLC | Pfizer Manufacturing Belgium NV | Pfizer Ireland Pharmaceuticals Unlimited Company2025-12-18HUMAN PRESCRIPTION DRUG LABEL
SOMAVERTPharmacia and Upjohn Company LLC | FUJIFILM Diosynth Biotechnologies U.S.A., Inc | Baxter Healthcare Corporation | Pfizer Manufacturing Belgium NV | Pfizer Ireland Pharmaceuticals | Amgen Technology (ireland) Unlimited Company2020-04-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-5201-04SOMAVERT1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1 mL25 mg in 1mL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-5201SOMAVERT (PEGVISOMANT) KIT [PHARMACIA & UPJOHN COMPANY LLC]11Unmatched20240413_3cbb485b-6df1-49ce-8747-592b395b1988.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PEGVISOMANTACTIVE INGREDIENTN824AOU5XVSOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]18
PEGVISOMANTACTIVE MOIETYN824AOU5XVSOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]18
GLYCINEINACTIVE INGREDIENTTE7660XO1CSOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]18
MANNITOLINACTIVE INGREDIENT3OWL53L36ASOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]18
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FSOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]18
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNSOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]18

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 3 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
SOMAVERTPEGVISOMANTPharmacia & Upjohn Company LLC3cbb485b-6df1-49ce-8747-592b395b19882025-12-18Warnings, Adverse reactionsExact identifier
application number: BLA021106
ndc (package): 0009-7188-30
ndc (package): 0009-5179-02
ndc (package): 0009-7166-30
ndc (package): 0009-7168-30
ndc (package): 0009-5175-02
ndc (package): 0009-7200-30
ndc (package): 0009-7199-30
ndc (package): 0009-7188-01
ndc (package): 0009-5376-04
ndc (package): 0009-7166-01
ndc (package): 0009-5177-02
ndc (package): 0009-5936-01
ndc (package): 0009-7168-01
ndc (package): 0009-7200-01
ndc (package): 0009-5201-04
ndc (package): 0009-7199-01
ndc (product): 0009-7199
ndc (product): 0009-7168
ndc (product): 0009-7188
ndc (product): 0009-7200
ndc (product): 0009-7166
rxcui: 1549323
rxcui: 403808
rxcui: 1549452
rxcui: 403806
rxcui: 1549456
rxcui: 1549454
rxcui: 404458
rxcui: 403807
rxcui: 404459
rxcui: 404457
spl id: 36dc9264-0f75-4059-ac68-65fa4bfcdcc2
spl set id: 3cbb485b-6df1-49ce-8747-592b395b1988
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 593YOG76RN
Uretron D/SMETHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticalsea74f1aa-2b4d-4ccf-e053-2995a90abab52025-12-18Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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