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 12 of 62 · 1,224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips Oasis Pineapple CoconutDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companyc504463a-28bf-4161-875f-ef73520931c52026-03-25WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice Cherry, SPF 15 CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37f2c3a6-7790-c8ec-e063-6294a90ace222026-03-25WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice - Original, SPF 15 OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37dc44aa-17b2-8721-e063-6294a90a34f62026-03-25WarningsExact identifier
unii: 92RU3N3Y1O
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
FelbamateFELBAMATEBryant Ranch Prepack6afd77f2-4525-42f4-a4b1-94159c401dd22026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X72RBB02N8
FelbamateFELBAMATEBryant Ranch Prepackd6eaf094-09e2-480c-bea9-7a2768aad8842026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X72RBB02N8
FelbamateFELBAMATEBryant Ranch Prepack696e3cbb-a431-4f29-acbd-1db8e9aaef932026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X72RBB02N8
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Softlips VanillaDIMETHICONEThe Mentholatum Company56551008-a4e0-406f-8403-980d2e6b75a02026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company29220eaa-87cb-4ebe-87db-d36288b3a9e42026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Selan Plus Zinc OxideSELAN PLUS ZINC OXIDETrividia Manufacturing Solutions, Inc07396c61-1dfd-4be7-bddf-0eb570a184632026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
Extra Strength Gas ReliefSIMETHICONEGrocery Outlet, Inc.44672e28-3305-a8cc-e063-6394a90a5fef2026-03-23WarningsExact identifier
unii: 92RU3N3Y1O
gas reliefSIMETHICONEBIONPHARMA INC.4d7a9507-6f3c-6d15-e063-6294a90a01602026-03-20WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Extra StrengthSIMETHICONEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ea6e04dd-4f57-4a88-b269-af38732915b32026-03-19WarningsExact identifier
unii: 92RU3N3Y1O
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.410d80fc-e55b-08d0-e063-6294a90aba732026-03-18WarningsExact identifier
unii: 92RU3N3Y1O
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.42477582-3ffa-4e51-a29b-86da07b143822026-03-17WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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