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 10 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
K Phos NeutralSODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEBeach Products, Inc.83376725-ee0f-40ad-bd90-31a61b9445cf2023-02-23Adverse reactionsExact identifier
unii: 22ADO53M6F
unii: 593YOG76RN
RejuvesolSODIUM PYRUVATE, INOSINE, ADENINE, SODIUM PHOSPHATE, DIBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATECitra Labs, LLCbc06c40f-81a0-45e5-80b6-61f67d4450682023-02-14WarningsExact identifier
unii: 593YOG76RN
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
NAT. PHOS.SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHyland's Inc.9ad86f9f-df9e-4e5c-bce4-571e1da441452022-12-19WarningsExact identifier
unii: 22ADO53M6F
HGH COMPLEXARGININE PYROGLUTAMATE, COLEUS FORSKOHLII, GLUTAMINE, GLYCINE, LYSINE, MUCUNA PRURIENS, ORNITHINE ALPHA-KETOGLUTARATE, TRIBULUS TERRESTRIS, TYROSINE, CDP-CHOLINE, GABAProBlen2b7ee28f-474e-414b-bf74-8b2baf3829472022-11-30WarningsExact identifier
unii: TE7660XO1C
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: 593YOG76RN

Reported adverse events (FAERS/openFDA)#

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