NDC 68071-4500-01 - Terbinafine Hydrochloride

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: 68071-4500
Requested NDC: 68071-4500-01
Package NDCs from labels: 68071-4500-1, 68071-4500-01
Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2024-06-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Terbinafine Hydrochloride - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4500-1	2022-02-07	C162847	48780-1	d6a99b39-879c-a426-e053-dadaa90af4c2	These 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
68071-4500-1	2022-01-28	C162847	48780-1	d6a99b39-879c-a426-e053-dadaa90af4c2	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4500-1	Terbinafine Hydrochloride	100 in 1 BOTTLE	TABLET	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4500	TERBINAFINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240612_715cae3e-4e86-48b3-e053-2a95a90afdc2.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 4 of 36 · 701 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BM Silicea	SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	53bb3927-6053-eb3d-e063-6394a90a5ddf	2026-06-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
Scrofularoforce	RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA	BioActive Nutritional, Inc.	737cd410-0405-41b0-b7f2-29bb20037849	2026-06-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
VAX	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,	BioActive Nutritional, Inc.	faa4a678-321a-4982-a5d4-01b713e6862d	2026-06-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
Vermex	ARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUM	BioActive Nutritional, Inc.	6be5fbcf-bb22-4b20-b65a-d943c516adf9	2026-06-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM Silicea Icing Sugar	SILICEA ICING SUGAR	Total Operations Management LLC DBA:Bestmade Natural Products Micro	535ba100-627f-36b4-e063-6394a90a3373	2026-06-03	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rohto Digi-Eye	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE	The Mentholatum Company	5d6f37b9-b568-4cb6-92de-eb40779f3f8c	2026-06-03	Warnings	Exact identifier unii: 3NXW29V3WO
BM Tooth Remineralization	CALC PHOS, CALC FLUOR, SILICEA	BM Private Limited	5331dc40-2ac8-5fce-e063-6394a90a5875	2026-06-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Dentaforce	ANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUM	BioActive Nutritional, Inc.	82321547-e04a-42ff-aa39-6a192638e5a2	2026-05-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
C07 STRONG LIGAMENTS AND JOINTS	ARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALE	Apex Energetics Inc.	bccf8c83-a6cd-e58c-e053-2a95a90a43d7	2026-05-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Acne Relief	BELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHUR	NaturalCare	487b1373-b78c-4510-964a-6ab0fe781ff4	2026-05-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
Dentastat	ALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUM	Energique, Inc.	12786efd-df42-4321-bfdf-88f542d387bb	2026-05-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Age Defiance Pro	7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONE	Energique, Inc.	d528bdbe-fb75-4b13-9cbc-efa2177d74d8	2026-05-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Pollen Hayfever	ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUM	NaturalCare	00665933-176e-4f16-b6ee-b55217b8abb3	2026-05-05	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydrate I	COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA	BioActive Nutritional, Inc.	c0c8d350-0257-4484-acd8-f852350173db	2026-04-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
TERBINAFINE HYDROCHLORIDE	TERBINAFINE TABLETS 250 MG	Golden State Medical Supply, Inc.	50750500-6cb0-62dc-e063-6294a90a15bc	2026-04-27	Warnings, Adverse reactions	Exact identifier rxcui: 313222 unii: 012C11ZU6G
Dentastat	ALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUM	Energique, Inc.	7f6d360b-9fee-4374-a47c-847806d54fa0	2026-04-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Exovisse Preservative-Free Artificial Tears	LUBRICANT EYE GEL DROPS	YD BIO USA, INC.	4f20191a-9124-2525-e063-6294a90a8428	2026-04-10	Warnings	Exact identifier unii: 3NXW29V3WO
Animal Hair and Dander	ADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEA	NaturalCare	f0067255-9310-43a0-b415-c03a0f554bcc	2026-04-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Quantum Resonance	ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM	Deseret Biologicals, Inc.	f94a10bd-1c40-42c7-b458-b58070614549	2026-04-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Quantum Resonance	ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM	Deseret Biologicals, Inc.	1467111a-bef6-473d-b7f2-3309a9bb72ce	2026-04-10	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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