FDA.reportPublic FDA data

NDC 16729-572 - Clobazam

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
16729-572
Package NDCs from labels
16729-572-63
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2023-11-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clobazam - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2023-11-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-572-63Clobazam1 in 1 CARTONSUSPENSION12
16729-572-63Clobazam120 mL in 1 BOTTLESUSPENSION1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-572CLOBAZAM SUSPENSION [ACCORD HEALTHCARE INC.]22 package rows20240906_e827ced8-dc40-9bd3-e053-2a95a90ae795.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 32 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive infants Gas reliefSIMETHICONEStrategic Sourcing Services LLC824c9dff-0a26-4710-a25b-39df631d6fa62024-12-13WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLC7ce312ca-542b-4bc0-97b5-f65279e1e84c2024-12-13WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Maximum Strength Classic FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.56853b20-a2aa-4b19-a428-3dde232114c62024-12-11WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta New Tonight Soothing Honey ChamomileCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.123f3005-a0a0-4970-94f1-f6d04741078b2024-12-11WarningsExact identifier
unii: 92RU3N3Y1O
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.fd160cfd-9ad4-81c7-e053-6394a90a33f62024-12-11WarningsExact identifier
unii: 92RU3N3Y1O
Blistex MedicatedDIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOLBlistex Inc.e95439d3-f12b-4c1c-999a-79f2ddba4cfb2024-12-11WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.74823298-d24a-4ffe-8446-1661305372b22024-12-11WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.ce2edc57-e550-4aa9-bbfe-37933913c9eb2024-12-11WarningsExact identifier
unii: 92RU3N3Y1O
Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.c8173d42-f900-4527-aa56-472d1177a9bc2024-12-11WarningsExact identifier
unii: 92RU3N3Y1O
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Blistex Five Star Lip Protection Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONEBlistex Inc.47b57317-7df5-442e-a3a4-1d44fe278ac62024-12-10WarningsExact identifier
unii: 92RU3N3Y1O
Deep Renewal Broad SpectrumDIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATEBlistex Inc11c0e084-dc40-4969-a176-3af4116d6f272024-12-10WarningsExact identifier
unii: 92RU3N3Y1O
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpb8712a98-30b7-4154-a5bf-0095ef9014122024-12-09WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp25c93d2a-3c48-ca3a-e063-6294a90a312e2024-12-09WarningsExact identifier
unii: 92RU3N3Y1O
BOA VIDA Recovery CremeDIMETHICONECentral Solutions Incbfa07058-7a20-4b9f-bad1-4b9fb5c037e02024-12-09WarningsExact identifier
unii: 92RU3N3Y1O
BOA VIDA CanopyDIMETHICONECentral Solutions Inc44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf2024-12-09WarningsExact identifier
unii: 92RU3N3Y1O
BOA VIDA CleansingDIMETHICONECentral Solutions Inc0b456b20-ab06-4adf-b5f0-1693d33979df2024-12-09WarningsExact identifier
unii: 92RU3N3Y1O
SOOTHE Sensitive Skin TreatmentALLANTOIN, DIMETHICONERodan & Fields2bd8cac4-5f40-4d04-91f2-3ea8a138033b2024-12-09WarningsExact identifier
unii: 92RU3N3Y1O
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3cdfa932-6a20-2a82-e054-00144ff88e882024-12-05WarningsExact identifier
unii: 92RU3N3Y1O
ClobazamCLOBAZAMBionpharma Inc.4b92ac57-25aa-4c00-b062-dee3944b271b2024-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1366192
unii: 2MRO291B4U

Reported adverse events (FAERS/openFDA)#

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