FDA.reportPublic FDA data

NDC 50090-3575-01 - Terbinafine

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
50090-3575
Requested NDC
50090-3575-01
Package NDCs from labels
50090-3575-0, 50090-3575-1, 50090-3575-01
Manufacturer
A-S Medication Solutions
Effective date
2025-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Terbinafine - A-S Medication SolutionsA-S Medication Solutions2025-12-18Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-3575-02023-02-07These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
50090-3575-12023-02-07These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
50090-3575-02023-01-30These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
50090-3575-12023-01-30These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3575-0Terbinafine30 in 1 BOTTLETABLET309
50090-3575-1Terbinafine90 in 1 BOTTLE, PLASTICTABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3575TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230208_5de4c245-7086-453b-b90a-7a1242ec2c0b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3575-0EA - Each50090-357514335135-ca30-4d17-bcca-99a8873de4f312021-11-09
50090-3575-1EA - Each50090-3575d8ab47fd-4b2c-4232-8ace-1fd36fb433b712021-11-09

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 23 of 34 · 669 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.Energique, Inc.76c6b494-43d1-4508-bea4-4f9026b4a5fa2024-10-29WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 30XSILICON DIOXIDETrue Botanica, LLC1d99c26a-3f95-c138-e063-6294a90a9d622024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ed3e0362-a4d3-46fa-a045-17bf659b777c2024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmuparARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEAEnergique, Inc.8b01e718-83b7-4f93-8fea-d0e37c7561852024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
FATIGUE NOSODE EBASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARANEA DIADEMA, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, SEPIA, EPSTEIN-BARR VIRUS NOSODEEnergique, Inc.36d963cc-fd47-40ee-aa73-c2e7fcedf1922024-10-24WarningsExact identifier
unii: ETJ7Z6XBU4
Complexion HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMEnergique, Inc.ad12d51e-04cb-4833-b802-0038796966ff2024-10-24WarningsExact identifier
unii: ETJ7Z6XBU4
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEA-S Medication Solutions8f6d7b1a-5a01-4cc5-b5b7-c126ae8895572024-10-14Warnings, Adverse reactionsExact identifier
rxcui: 313222
unii: 012C11ZU6G
Granite 30XGRANITE 30XTrue Botanica, LLC21b2bae6-8176-ccbf-e063-6394a90a97b52024-10-07WarningsExact identifier
unii: ETJ7Z6XBU4
EMF Protect and BalanceALFALFA, CADMIUM SULPHURATUM, CALCAREA CARBONICA, CUPRUM METALLICUM, FERRUM METALLICUM, FUCUS VESICULOSUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, SILICEA, SYMPHYTUM OFFICINALE, TARENTULA CUBENSIS, X-RAY, YTTERBIUM OXIDEDeseret Biologicals, Inc.9ea8dfe3-7d95-4b86-8e1f-dc9e414e854a2024-10-04WarningsExact identifier
unii: ETJ7Z6XBU4
Hydration ComplexBOLDO, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, HYPERICUM PERFORATUM, GINKGO BILOBA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, GERMANIUM SESQUIOXIDE, SILICEA, CALCAREA FLUORICA, CALCAREA PHOSPHORICADeseret Biologicals, Inc.891265ff-2651-4d84-a77b-331e3eb7e3ec2024-10-04WarningsExact identifier
unii: ETJ7Z6XBU4
Bone Support HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPATORIUM PERFOLIATUM, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, STRONTIUM CARBONICUM, SYMPHYTUM OFFICINALEEnergique, Inc.da6937b9-da23-4e78-96af-2ca40f973a022024-09-30WarningsExact identifier
unii: ETJ7Z6XBU4
LymphaparECHINACEA (ANGUSTIFOLIA), LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM , KALI MURIATICUM, LACHESIS MUTUS, SILICEAEnergique, Inc.c746c111-7ebc-46c1-b11b-04271887df9c2024-09-23WarningsExact identifier
unii: ETJ7Z6XBU4
HP AxisARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONEDeseret Biologicals, Inc.402f5b05-c71e-4dba-bc2b-049aee42952a2024-09-23WarningsExact identifier
unii: ETJ7Z6XBU4
ChronagesicARNICA MONTANA, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, SANGUINARIA CANADENSIS, SULPHUR, PIPER NIGRUM, ALPHA-LIPOICUM ACIDUM, CARTILAGO SUIS, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALIS, APIOLUMDeseret Biologicals, Inc.66e351ed-d359-4367-a950-fc57b37489ab2024-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
VACC HCANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LAC FELINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, RNA, SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Deseret Biologicals, Inc.a7536e3d-2cdb-49d7-9161-92ef644338832024-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
FocusGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGERDeseret Biologicals, Inc.e77857b8-be67-4041-8c8d-9772f17c6d062024-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
MammaryplexECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE)BioActive Nutritional, Inc.9c9ed6f6-8690-4fbd-8691-26dd577014a82024-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph LiquescenceECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ARSENICUM IODATUM, CURCUMA LONGA, SPLEEN (BOVINE), THYMUS (OVINE), CONIUM MACULATUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, SILICEA, ASTERIAS RUBENS, HYDRASTIS CANADENSIS, BUFO RANANutritional Specialties, Inc.866ac8e1-431c-4c8b-b052-f6c4cff3769b2024-09-05WarningsExact identifier
unii: ETJ7Z6XBU4
TerbinafineTERBINAFINE HYDROCHLORIDEProficient Rx LP0a54cc4f-0789-46ce-875f-df759aa95d9c2024-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA078297
rxcui: 313222
unii: 012C11ZU6G
Geopathic StressALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, SYMPHYTUM OFFICINALE, AGATE, CALCAREA CARBONICA, FERRUM METALLICUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, X-RAY, CUPRUM METALLICUM, TARENTULA HISPANABioActive Nutritional, Inc.7f4a18fc-1188-4201-85d5-f2d4d9d3fb7b2024-08-29WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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