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 118 of 155 · 3,091 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASPECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BRYONIA (ALBA), COCCULUS INDICUS, COLCHICUM AUTUMNALE, LEDUM PALUSTRE, MERCURIUS CYANATUS, NATRUM SULPHURICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, AFLATOXIN (B1)BioActive Nutritional, Inc.66fe5457-fe15-4e33-b47e-2c0dc9b171f62024-08-28WarningsExact identifier
unii: ETJ7Z6XBU4
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: Z0H242BBR1
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDermio Dermatology LLC204973ce-dba4-8235-e063-6394a90a015c2024-08-22WarningsExact identifier
unii: 15FIX9V2JP
MirtazapineMIRTAZAPINEBryant Ranch Prepackecf7826c-c583-4836-9b00-bf9e4b51a1442024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
unii: A051Q2099Q
Insect sting relief latex 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b9e2d4c-bc0c-6ed0-e063-6294a90a91032024-08-19WarningsExact identifier
unii: 8MDF5V39QO
MACKENZIES OCEAN SAFE SUNSCREENTITANIUM DIOXIDENaturally Uncommon, LLC1fd0a790-c66c-216f-e063-6294a90ae9712024-08-16WarningsExact identifier
unii: 15FIX9V2JP
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: 8MDF5V39QO
VermiclearGRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUMEnergique, Inc.f9df74a8-f225-44ca-91ba-dca4f3f35da02024-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Omeprazole/Sodiium BicarbonateOMEPRAZOLE/SODIIUM BICARBONATEDirect_rx1f7f63c1-17c2-9a05-e063-6394a90abc6f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1f4491ab-95b0-cc14-e063-6394a90a73ca2024-08-09WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb737146d-fb50-4ed6-ab5e-6aff3393992a2024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior54b07420-6a30-4481-99f5-a7d6a4df898c2024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65659277-cd30-453c-929e-3651c9f19da82024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior28ae9c39-eb79-4a19-8149-af8d8e7901ae2024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior05f7119a-0c92-4393-a62d-8e84ec451d202024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb90ee1ba-17b5-4367-9df3-e9e27217960c2024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorad5c5121-d75d-449d-a4db-a7b074787f682024-08-06WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00OCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0018573d-922b-4642-9513-63481e9131d52024-08-06WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior83b20b0d-c2db-4720-8434-57b73847ebca2024-08-06WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior105651f2-3c99-4ff3-b67b-350a40dc88882024-08-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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