FDA.reportPublic FDA data

NDC 0052-0110-06 - 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
0052-0110
Requested NDC
0052-0110-06
Package NDCs from labels
0052-0110-06, 0052-0110-30
Manufacturer
Organon USA Inc.
Effective date
2021-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
REMERON - Organon USA Inc.Organon USA Inc.2021-10-08HUMAN PRESCRIPTION DRUG LABEL
ONCE-A-DAY REMERONSolTab ® (mirtazapine) Orally Disintegrating TabletsOrganon USA Inc.2019-09-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0052-0110-06EA - Each0052-011072a54409-5acd-47ff-81cc-26713bbb956412015-12-02
0052-0110-30EA - Each0052-011042102ee0-32e6-4c79-8c77-15e52a1b4bc912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QREMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
MIRTAZAPINEACTIVE MOIETYA051Q2099QREMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
CROSPOVIDONEINACTIVE INGREDIENT68401960MKREMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOREMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
MANNITOLINACTIVE INGREDIENT3OWL53L36AREMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
POVIDONESINACTIVE INGREDIENTFZ989GH94EREMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOREMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
SUCROSEINACTIVE INGREDIENTC151H8M554REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]20
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QREMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]19
MIRTAZAPINEACTIVE MOIETYA051Q2099QREMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]19
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PREMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]19
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GREMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]19
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]19
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJREMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]19

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 1 of 158 · 3,153 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
MirtazapineMIRTAZAPINENCS HealthCare of KY, LLC dba Vangard Labs63f140c2-2a18-4dea-96fe-2658dda28a0c2026-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MirtazapineMIRTAZAPINEREMEDYREPACK INC.412abf0e-1f96-4d4d-bb56-a23d4699b14c2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MirtazapineMIRTAZAPINENuCare Pharmaceuticals,Inc.d6fbe837-988a-7c75-e053-2995a90a599a2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
MirtazapineMIRTAZAPINENuCare Pharmaceuticals,Inc.e38c96d4-ea33-3f1a-e053-2a95a90a09032026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q

Reported adverse events (FAERS/openFDA)#

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