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 125 of 155 · 3,091 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.7e3a254b-a43d-43a2-a777-0d0c0057e1312024-03-14WarningsExact identifier
unii: C151H8M554
BB Blanc 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137a1528-c487-8bf3-e063-6294a90ade842024-03-12WarningsExact identifier
unii: 15FIX9V2JP
BB Sienna 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137bff4a-5156-b12c-e063-6394a90abe632024-03-12WarningsExact identifier
unii: 15FIX9V2JP
VerARTEMISIA VULGARIS, ASCARIS LUMBRICOIDES, BRUGIA MALAYI, CALCAREA CARBONICA, CINA, CRYPTOSPORIDIUM PARVUM, ENTEROBIUS VERMICULARIS, FILIX MAS, GIARDIA LAMBLIA, GRAPHITES, IODIUM, MERCURIUS CORROSIVUS, QUASSIA (AMARA), SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TAENIA SAGINATA, TAENIA SOLIUM, TEUCRIUM MARUM, THYMUS SERPYLLUM, TRICHINELLA SPIRALIS, TRICHOMONAS VAGINALISDeseret Biologicals, Inc.b47bdd57-14cd-46e9-a34e-0d8a7c21bda22024-03-12WarningsExact identifier
unii: ETJ7Z6XBU4
BB Brite 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13660aee-3b28-7e3e-e063-6294a90a82cc2024-03-11WarningsExact identifier
unii: 15FIX9V2JP
BB Bronze 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13679e50-01ef-9a8f-e063-6294a90ac5772024-03-11WarningsExact identifier
unii: 15FIX9V2JP
BB Noir 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs136a7f66-844c-b16a-e063-6294a90aa9752024-03-11WarningsExact identifier
unii: 15FIX9V2JP
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact identifier
unii: ETJ7Z6XBU4
SpinalmaxBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUMDeseret Biologicals, Inc.6c569331-2167-44bb-ace6-13340e7d8d6a2024-03-11WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH), L-TRYPTOPHAN, MELATONIN, MERCURIUS CORROSIVUS, PANTOTHENIC ACID, PASSIFLORA INCARNATA, PINEAL GLAND (SUIS), PYRROLE, SARCOLACTICUM ACIDUM, SILICEA, UBIDECARENONUM, ZINCUM VALERIANICUMDeseret Biologicals, Inc.81f29472-a2e6-486d-aefd-17135ad410ef2024-03-08WarningsExact identifier
unii: ETJ7Z6XBU4
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: C151H8M554
unii: J2B2A4N98G
Cand PlusHYDRASTIS CANADENSIS, BERBERIS VULGARIS, BORAX, SACCHARUM OFFICINALE, CAFFEINUM, GALLICUM ACIDUM, INDOLUM, ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), ASAFOETIDA, ACETALDEHYDE, FOLLICULINUM, LYCOPODIUM CLAVATUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), SEPIA, USTILAGO MAIDIS, TORULA CEREVISIAEDeseret Biologicals, Inc.1f8ab864-27c2-4457-8ad7-5d65f9983e2c2024-03-06WarningsExact identifier
unii: C151H8M554
Brush On Block Sun Shine SPF 30 Protective Lip Oil Nude TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e5493f-6478-0ff4-e063-6394a90af4f52024-03-05WarningsExact identifier
unii: 15FIX9V2JP
Brush On Block Sun Shine SPF 30 Protective Lip Oil CoralTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e65634-2e6d-b030-e063-6294a90ad1c42024-03-05WarningsExact identifier
unii: 15FIX9V2JP
Brush On Block Sun Shine SPF 30 Protective Lip Oil FigTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e7507d-6612-fda4-e063-6294a90a1db72024-03-05WarningsExact identifier
unii: 15FIX9V2JP
Sodium BicarbonateSODIUM BICARBONATESteriscience Specialties Private Limitedeb2996b4-c04c-4678-b8a9-5cbbe509bb702024-03-04Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
BB Tint 30 BS SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs1212448c-db88-26e6-e063-6294a90a3b9e2024-02-23WarningsExact identifier
unii: 15FIX9V2JP
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirsta5eedf57-2783-b3d0-e053-2a95a90a9ff52024-02-22Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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