FDA.reportPublic FDA data

NDC 69616-265 - AGAMREE

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
69616-265
Package NDCs from labels
69616-265-38
Manufacturer
Catalyst Pharmaceuticals, Inc. | Allpack Group AG | Farmabios S.p.A | Purna Pharmaceuticals NV/SA
Effective date
2026-01-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AGAMREECatalyst Pharmaceuticals, Inc. | Allpack Group AG | Farmabios S.p.A | Purna Pharmaceuticals NV/SA2026-01-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69616-265-38AGAMREE100 mL in 1 BOTTLE, GLASSSUSPENSION100 mL40 mg in 1mL10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69616-265AGAMREE (VAMOROLONE) KIT [CATALYST PHARMACEUTICALS, INC.]7Unmatched20250413_fb376f09-cf9c-42b5-b4dd-02d5bcd73211.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 21 of 29 · 563 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: PDC6A3C0OX
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
unii: PDC6A3C0OX
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Zenibell Snail IntensiveCreamGLYCERINMISOCOS97c19dca-237c-c968-e053-2a95a90aeae72024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail Intensive TonerGLYCERINMISOCOS97c1b556-824d-bef7-e053-2a95a90ae1f22024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma HydrocellGLYCERINMISOCOS980fcaea-27ba-da49-e053-2995a90ad5062024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma Hydrocell 24k Gold SerumGLYCERINMISOCOSa17b2c6e-9db8-bae4-e053-2a95a90adcf62024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail IntensiveGLYCERINMISOCOS97747267-26f1-d06f-e053-2a95a90ab0872024-07-04WarningsExact identifier
unii: PDC6A3C0OX
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
unii: PDC6A3C0OX
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
unii: PDC6A3C0OX
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSAmerican Regent, Inc.dc0462ee-4486-418c-865f-e2a71bdb8e9e2024-06-06Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 2968PHW8QP
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Phenylacetate and Sodium BenzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEFOSUN PHARMA USA INCcee1e9a2-bbe5-2419-e053-2a95a90ac3ef2024-05-09Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Fatigue Stat CMECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODEEnergique, Incaebdb08b-48aa-46f2-930f-f98f5b06a6042024-05-08WarningsExact identifier
unii: QTT17582CB
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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