FDA.reportPublic FDA data

NDC 78206-159-99 - REMERON

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
78206-159
Requested NDC
78206-159-99
Package NDCs from labels
78206-159-99, 78206-159-01
Manufacturer
Organon LLC
Effective date
2025-08-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
REMERON - Organon LLCOrganon LLC2025-08-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-159-01REMERONSOLTAB5 in 1 BOXTABLET, ORALLY DISINTEGRATING58
78206-159-99REMERONSOLTAB6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-159REMERON (MIRTAZAPINE) TABLET, FILM COATED REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON LLC]7Current NDC, Legacy NDC, 2 package rows20250312_98ad1917-a094-44f5-a28f-a64a8cfcd887.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-159-01EA - Each78206-15998fe26eb-d931-4554-9c87-441c5ea43a5612021-09-07
78206-159-99EA - Each78206-1591a97ed28-b540-4a81-88e4-52ad2bf4294a12021-09-07

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 113 of 155 · 3,091 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYfef47045-1d3c-4f08-acec-e96abefbc2612024-11-08WarningsExact identifier
unii: 15FIX9V2JP
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY547388c6-378b-488b-89d1-c77ebc5d2ed82024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 SUMMER BLEND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY9641b71a-81f2-4157-801b-162188392a912024-11-07WarningsExact identifier
unii: 15FIX9V2JP
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLCf7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f2024-11-07WarningsExact identifier
unii: 8MDF5V39QO
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd79cf2d9-4923-452a-bb44-67e059ee37ee2024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd4f30d95-4a3f-49ad-817e-faa86fca50182024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 CALENDULA SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY64580be7-868c-40fb-b7b8-840b417b25d32024-11-06WarningsExact identifier
unii: 15FIX9V2JP
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
unii: 15FIX9V2JP
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
unii: 15FIX9V2JP
Sinus Congestion HeadacheANTIMONIUM TARTARICUM, ASAFOETIDA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIA PILULIFERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MUCOSA NASALIS SUIS, PULSATILLA (PRATENSIS), PYROGENIUM, SILICEA, TEUCRIUM MARUMLiddell Laboratories, Inc.debc7747-8664-4598-a862-e295188c4fca2024-11-04WarningsExact identifier
unii: ETJ7Z6XBU4
VaccinesARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENSLiddell Laboratories, Inc.6e6e67d4-089e-4775-b4a4-5511953f6e3f2024-11-04WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium BicarbonateSODIUM BICARBONATERising Pharma Holdings, Inc.f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e2024-11-01Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.8c8d63b6-763a-44f8-87ef-e83a89ec37762024-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.5205cc3e-c9bc-48e9-9c9b-959a9be78b852024-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: 15FIX9V2JP
unii: Z0H242BBR1
SiliceaSILICEAEnergique, Inc.7ac17e38-d6e2-4cc9-8fcb-cbfa0d60223b2024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
ScarstatCALENDULA OFFICINALIS, GRAPHITES, HYPERICUM PERFORATUM, SILICEA, STAPHYSAGRIA, THIOSINAMINUMEnergique, Inc.1decc2eb-1261-46b8-908e-a152535b4a022024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEASILICEAEnergique, Inc.395f400d-6a87-4da9-aa1f-edca9729f1ac2024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
Scrophulous HPBARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, GNAPHALIUM POLYCEPHALUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEAEnergique, Inc.e50eb26b-6843-4b8f-8ea5-3d5f57a3e7b42024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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