FDA.reportPublic FDA data

NDC 51672-4185-01 - Felbamate

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
51672-4185
Requested NDC
51672-4185-01
Package NDCs from labels
51672-4185-6, 51672-4185-1, 51672-4185-5, 51672-4185-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.
Effective date
2026-06-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Felbamate Tablets USP 400 mg and 600 mgSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.2026-06-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4185-1Felbamate100 in 1 BOTTLETABLET1006
51672-4185-5Felbamate90 in 1 BOTTLETABLET906
51672-4185-6Felbamate30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4185FELBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 3 package rows20231216_f2edb3ed-da20-4093-88ea-00fe781e47e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4185-1EA - Each51672-4185b34f1c09-3976-45d4-8f8c-a0e58575c8c312017-11-06

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 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FelbamateFELBAMATEViona Pharmaceuticals Inc96f4357c-720c-4651-b638-7b1181531dc52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198359
rxcui: 198358
unii: X72RBB02N8
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: LMI26O6933
Metex 6013METEXProfessional Complementary Health Formulas78371ca3-50a6-46f0-8ea6-7de57c5163752026-01-08WarningsExact identifier
unii: LMI26O6933
H-Clenz Drops 2026H-CLENZ DROPSProfessional Complementary Health Formulas5dd76d36-e3db-472a-82f8-30643e49eaf72026-01-08WarningsExact identifier
unii: LMI26O6933
Alumina Combination 9204ALUMINA COMBINATIONProfessional Complementary Health Formulas312cac13-2009-4b8f-a09b-9be2d2801df52026-01-08WarningsExact identifier
unii: LMI26O6933
Alopecia Formula 2139ALOPECIA FORMULAProfessional Complementary Health Formulasce0eaf67-a435-4167-b9ce-c0ff1f8a9dc22026-01-08WarningsExact identifier
unii: LMI26O6933
Colic Drops 2155COLIC DROPSProfessional Complementary Health Formulas17b9e92f-f4ed-48b4-ab02-8b7cba0a20272026-01-08WarningsExact identifier
unii: LMI26O6933
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALOE, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUMEnergique, Inc.3ddbed50-7ca9-493c-ba94-321c2afef60e2026-01-06WarningsExact identifier
unii: LMI26O6933
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: LMI26O6933
CONSTIPATIONMAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEANatural Creations, Inc.d2e24f5a-747b-4d62-bbdf-16c0e43becdb2025-11-21WarningsExact identifier
unii: LMI26O6933
Berberis ViscumBERBERIS VISCUMUriel Pharmacy Inc.30abbbd6-1657-4959-9f07-85ddf45f11192025-11-14WarningsExact identifier
unii: LMI26O6933
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: LMI26O6933
FelbamateFELBAMATEANI Pharmaceuticals, Inc.17850520-f823-4d05-8f9b-5eadfa68bae22025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198359
rxcui: 198358
unii: X72RBB02N8
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICAEnergique, Inc.89c86e7b-304c-43a6-81e7-373d95c9fac12025-10-06WarningsExact identifier
unii: LMI26O6933
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: LMI26O6933
FelbatolFELBAMATEViatris Specialty LLC2f522701-397a-11de-8a39-0800200c9a662025-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198359
rxcui: 198358
unii: X72RBB02N8
Rena-ChordHOMEOPATHIC LIQUIDEnergetix Corporation4071f90a-8a28-4338-810b-c9b18cf32f872025-07-15WarningsExact identifier
unii: LMI26O6933
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

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