FDA.reportPublic FDA data

NDC 51672-4172-01 - 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
51672-4172
Requested NDC
51672-4172-01
Package NDCs from labels
51672-4172-1, 51672-4172-9, 51672-4172-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Felbamate Oral Suspension USP 600 mg/5 mLSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.2026-07-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4172-1Felbamate237 mL in 1 BOTTLESUSPENSION2373
51672-4172-9Felbamate473 mL in 1 BOTTLESUSPENSION4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4172FELBAMATE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 2 package rows20170623_0afffb17-e6ac-4bea-a90e-7ef3c8150290.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4172-1ML - Milliliter51672-4172b9e234bf-bcb9-4c4b-a0e0-f5f48955ad0812017-07-07
51672-4172-9ML - Milliliter51672-41722c09f0b8-bb48-4a6d-8f69-7eebafb066ed12017-07-07

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 59 of 61 · 1,210 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: PDC6A3C0OX
unii: 6OZP39ZG8H
unii: K679OBS311
FelbamateFELBAMATENovitium Pharma LLC81c8a2e1-732c-4467-84e9-53fef1655ee22022-09-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310285
unii: X72RBB02N8
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONECamber Consumer Care Ince2a4af66-1d05-408c-9f11-f2a9f325d75c2022-09-12WarningsExact identifier
unii: 92RU3N3Y1O
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 6OZP39ZG8H
unii: K679OBS311
Loperamide HCl and SimethiconeLOPERAMIDE HCL AND SIMETHICONEOhm Laboratories Inc.06f99f59-e702-49f1-bb1d-e7cf58c54c302022-08-30WarningsExact identifier
unii: 92RU3N3Y1O
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
unii: K679OBS311
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
unii: 6OZP39ZG8H
unii: K679OBS311
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
unii: K679OBS311
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Gas ReliefSIMETHICONEAllegiant Healthae98861e-6a26-4e0e-a66a-b2738d3cbddd2021-09-24WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAllegiant Health4c79535c-4372-4fd4-a91a-d93617cd581b2021-09-24WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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