FDA.reportPublic FDA data

NDC 0052-0108-06 - 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
0052-0108
Requested NDC
0052-0108-06
Package NDCs from labels
0052-0108-06, 0052-0108-30
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
0052-0108-06EA - Each0052-01082a6b656a-6507-4ddb-90c8-9d0fa4472f3212015-12-02
0052-0108-30EA - Each0052-010864e4faad-98a3-4fda-a6dd-754d02437b2112012-07-24

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 8 of 158 · 3,153 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
unii: FZ989GH94E
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirstd8516f38-6f92-32d1-e053-2995a90a96bf2026-06-19Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium BicarbonateSODIUM BICARBONATE, INJECTIONCivica, Inc.3737e5e5-2296-4a3d-b8f1-dfea1eff19272026-06-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 8MDF5V39QO
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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