FDA.reportPublic FDA data

NDC 0093-7208-93 - 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
0093-7208
Requested NDC
0093-7208-93
Package NDCs from labels
0093-7208-56, 0093-7208-93
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2017-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mirtazapine Tablets USP 15 mg, 30 mg and 45 mg Rx onlyTeva Pharmaceuticals USA, Inc.2017-09-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7208-19EA - Each0093-72081d240d36-1c2f-4991-aa1a-9f9c277351c412012-07-24
0093-7208-56EA - Each0093-7208ca23c534-7741-416a-9f10-536249bec4b512012-07-24
0093-7208-93EA - Each0093-720882d7c64d-ad92-432c-bab6-4658df407e2512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13

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 2 of 142 · 2,822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
MirtazapineMIRTAZAPINECoupler LLC598e441a-aa1a-6fb3-e063-6394a90a14aa2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
MirtazapineMIRTAZAPINERedpharm Drug58bea4d8-084f-4c30-e063-6394a90a35cb2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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