FDA.reportPublic FDA data

NDC 68084-121-11 - Mirtazapine

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
68084-121
Requested NDC
68084-121-11
Package NDCs from labels
68084-121-11, 68084-121-01
Manufacturer
American Health Packaging
Effective date
2026-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mirtazapine - American Health PackagingAmerican Health Packaging2026-07-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-121-01Mirtazapine100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10014
68084-121-11Mirtazapine1 in 1 BLISTER PACKTABLET, FILM COATED114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-121MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]14Current NDC, Legacy NDC, 2 package rows20241004_82a615a0-e74a-49cb-9a57-ffbb3df604d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-121-01EA - Each68084-12108ac8dca-d0bf-48bc-96f3-51ee7989221612012-07-24
68084-121-11EA - Each68084-12193614fc9-7f60-4dcf-b919-0e920b57599712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MirtazapineACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
MirtazapineACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5

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 4 of 140 · 2,785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
MirtazapineMIRTAZAPINEREMEDYREPACK INC.10ea9d83-19c3-4f3b-a1cc-cfc48b42507f2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076921
rxcui: 476809
unii: A051Q2099Q
MirtazapineMIRTAZAPINECardinal Health 107, LLC89ae6a33-933f-47aa-a2de-2a71cd3f7d442026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
unii: A051Q2099Q
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
mirtazapineMIRTAZAPINEA-S Medication Solutions222dfdde-6979-4b18-a7eb-ff1ad0a437c12026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 476809
unii: A051Q2099Q
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
MirtazapineMIRTAZAPINEBryant Ranch Prepack577c3ceb-316b-4c93-9b0c-0a4b1b4773e92026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314111
unii: A051Q2099Q
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
MirtazapineMIRTAZAPINEREMEDYREPACK INC.9135e7db-cba4-4150-a69c-fdf2a347a7852026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076921
rxcui: 311725
unii: A051Q2099Q
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.c22c4325-4f1a-4d12-8039-d3b1263fa3ad2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076921
rxcui: 311725
unii: A051Q2099Q

Reported adverse events (FAERS/openFDA)#

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