FDA.reportPublic FDA data

NDC 68094-074-01 - 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
68094-074
Requested NDC
68094-074-01
Package NDCs from labels
68094-074-01, 68094-074-58
Manufacturer
Precision Dose, Inc.
Effective date
2025-08-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clobazam - Precision Dose, Inc.Precision Dose, Inc.2025-08-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-074-01Clobazam4 mL in 1 SYRINGE, PLASTICSUSPENSION42
68094-074-01Clobazam1 in 1 BAGSUSPENSION12
68094-074-58Clobazam50 in 1 CASESUSPENSION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-074CLOBAZAM SUSPENSION [PRECISION DOSE, INC.]1Current NDC, 3 package rows20250310_6332e71c-3b37-422c-838c-8a2489ac6009.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-074-01ML - Milliliter68094-07477d7dae4-0810-4b74-a525-1a8c0e174b5712025-05-14
68094-074-58ML - Milliliter68094-07476e74da1-69ec-42e2-b91e-28b6ec16da2812025-05-14

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 57 of 77 · 1,523 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOBAZAMCLOBAZAMNovadoz Pharmaceuticals LLCcf5bb37f-5386-47d3-8cec-d48253d359f62024-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2MRO291B4U
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEWalgreen Company0999243a-c3be-41a6-b327-962e63d8c3562024-07-22WarningsExact identifier
unii: 92RU3N3Y1O
dg health anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDolgencorp, LLC09798231-39cd-49b2-9be5-ea51e52f0a6d2024-07-22WarningsExact identifier
unii: 92RU3N3Y1O
Basic Care Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmazon.com Services LLCaa79234e-1fbd-4279-b4b1-46b4f041b4e82024-07-22WarningsExact identifier
unii: 92RU3N3Y1O
equaline anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEUnited Natural Foods, Inc. dba UNFI2ce0b37e-6dc4-423f-a1d6-a2cb623946d52024-07-22WarningsExact identifier
unii: 92RU3N3Y1O
up and up anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONETarget Corporationef75085c-95df-4901-9c97-069fcfc3eef72024-07-22WarningsExact identifier
unii: 92RU3N3Y1O
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEMeijer Distribution Ince2c9a752-618a-4e34-89a5-671aab4013ac2024-07-11WarningsExact identifier
unii: 92RU3N3Y1O
foster and thrive anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEStrategic Sourcing Services LLC9132dc1c-8e16-4236-881e-863f5e57f0ab2024-07-08WarningsExact identifier
unii: 92RU3N3Y1O
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
unii: ETJ7Z6XBU4
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Argentum Quartz 6XARGENTUM QUARTZ 6XTrue Botanica, LLC1acadf89-d222-9e16-e063-6294a90a80bc2024-06-26WarningsExact identifier
unii: ETJ7Z6XBU4
Gas Relief Ultra StrengthSIMETHICONEWalgreens00a9164a-1817-4130-9c7f-9f5833c9690f2024-06-26WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Ultra StrengthSIMETHICONEWalgreensaa074ceb-b86e-4a07-b885-b8fa6c1e0fcf2024-06-26WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Ultra StrengthSIMETHICONEWalgreens3e5821ec-d096-4f52-82d2-475056f45e4c2024-06-26WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Ultra StrengthSIMETHICONEWalgreens0050b639-5fb6-4503-ae73-e319cf0370272024-06-26WarningsExact identifier
unii: 92RU3N3Y1O
THERA Moisturizing Body ShieldDIMETHICONEMcKesson Medical-Surgical Inc.56869b64-11ee-4df6-8102-ce5818e0116e2024-06-18WarningsExact identifier
unii: 92RU3N3Y1O
DimethiconeSKIN PROTECTANTMcKesson96886b33-44d4-5a2a-e053-2a95a90a505e2024-06-18WarningsExact identifier
unii: 92RU3N3Y1O
ClobazamCLOBAZAMAmneal Pharmaceuticals NY LLCa526ad73-d3c1-40b7-8e71-426b01cdea272024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210039
ndc (product): 69238-1535
rxcui: 1366192
spl id: cf085b2b-564e-4109-90e7-1d27fcbca810
spl set id: a526ad73-d3c1-40b7-8e71-426b01cdea27
unii: 2MRO291B4U
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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