Home NDC 78206-159-99 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 Label Manufacturer Effective date Type REMERON - Organon LLC Organon LLC 2025-08-06 HUMAN PRESCRIPTION DRUG LABEL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78206-159-01 REMERONSOLTAB 5 in 1 BOX TABLET, ORALLY DISINTEGRATING 5 8 78206-159-99 REMERONSOLTAB 6 in 1 BLISTER PACK TABLET, ORALLY DISINTEGRATING 6 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-159 REMERON (MIRTAZAPINE) TABLET, FILM COATED REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON LLC] 7 Current NDC, Legacy NDC, 2 package rows 20250312_98ad1917-a094-44f5-a28f-a64a8cfcd887.zip
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 134 of 155 · 3,091 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Silicea SILICON DIOXIDE Boiron 86d2b8f2-dce0-c136-e053-2991aa0a0fdb 2023-11-15 Exact identifier unii: ETJ7Z6XBU4 Silicea SILICON DIOXIDE Boiron 86d31d98-dd71-870e-e053-2991aa0a0ce7 2023-11-15 Exact identifier unii: ETJ7Z6XBU4 Silicea SILICON DIOXIDE Boiron 86d3ffad-5be4-700a-e053-2991aa0a1cc9 2023-11-15 Exact identifier unii: ETJ7Z6XBU4 Silicea SILICON DIOXIDE Boiron 86d3206e-a893-3f0c-e053-2991aa0a149f 2023-11-15 Exact identifier unii: ETJ7Z6XBU4 Silicea SILICON DIOXIDE Boiron 86d3d6ca-8b63-2e63-e053-2991aa0a0e05 2023-11-15 Exact identifier unii: ETJ7Z6XBU4 Max Mineral TITANIUM DIOXIDE, ZINC OXIDE Peter Thomas Roth Labs, LLC 0980992c-6488-2fa1-e063-6294a90a41ea 2023-11-14 Warnings Exact identifier unii: 15FIX9V2JP Saccharum officinale SUCROSE Boiron 86d04552-b31a-0fcf-e053-2991aa0acecd 2023-11-14 Exact identifier unii: C151H8M554 Saccharum officinale SUCROSE Boiron 86d05561-6f09-6f1f-e053-2a91aa0a4b98 2023-11-14 Exact identifier unii: C151H8M554 Sodium Bicarbonate SODIUM BICARBONATE A-S Medication Solutions d89406d3-4356-4a8c-acc1-89efe1d27010 2023-11-14 Warnings, Adverse reactions Exact identifier unii: 8MDF5V39QO Tropical Sands, SPF-50 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 493551d0-10a0-3d78-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP Tropical Sands SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 494a7886-d677-1648-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP Tropical Sands SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. ab691543-e37a-487a-912e-56d2e0e4d30a 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP PURE HAVEN BODY SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Pure haven, LLC 6f298fcd-8a97-8f66-e053-2991aa0adb10 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP Sunstation All-Natural SPF 30 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sunstation USA, LLC 499d366a-a7f1-6070-e054-00144ff88e88 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP Pure Haven Essentials TITANIUM DIOXIDE, ZINC OXIDE Pure Haven LLC 4bccc017-266d-11ce-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Kapa'ihi, Inc 66e5eb1b-4ef0-459d-8428-b3e2f221bc85 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP YOU-V SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE YouV, LLC 290cd617-aa90-4f10-8a1d-d8954b927004 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30 TITANIUM DIOXIDE Coral Reef Park Co., Inc. 743f3d23-0f5c-4724-9f69-411c109506e1 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP ONCODERM Rx Mineral Sunscreen SPF-30 TITANIUM DIOXIDE, ZINC OXIDE Oncoderm, LLC 9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP PROJECT REEF Mineral Sunscreen SPF-50 ZINC OXIDE, TITANIUM DIOXIDE Project Reef LLC 87b9170c-956e-4aa2-9416-da00cca81b58 2023-11-11 Warnings Exact identifier unii: 15FIX9V2JP
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.