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 7 of 158 · 3,153 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
MirtazapineMIRTAZAPINEUnit Dose Solutions, Inc.5539fe37-546b-40a8-e063-6394a90ace1b2026-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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