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 37 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone 125 mgSIMETHICONEProficient Rx LP078ef54e-96b2-4e2f-bebc-9b9bcda1f90a2024-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAdvanced Rx LLC72de768c-c011-433b-be27-f1978d18f7d82024-08-30WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAdvanced Rx LLC57d31610-c658-49cf-9de3-01e8143aeace2024-08-30WarningsExact identifier
unii: 92RU3N3Y1O
QCH Maximum Strength Antacid 516ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.1794c35a-79c5-48c2-e063-6394a90a6d292024-08-28WarningsExact identifier
unii: 92RU3N3Y1O
QCH Regular Strength Antacid 509ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17947ccd-6f11-d4cd-e063-6294a90a108a2024-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17dfe539-923b-e623-e063-6294a90a041f2024-08-27WarningsExact identifier
unii: 92RU3N3Y1O
QCH Extra Strength Gas Relief Cherry Flavor 134CHRSIMETHICONEChain Drug Marketing Association Inc.17e3300c-3d31-b7e1-e063-6294a90af0822024-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Quality Choice Infants Non-staining Gas reliefSIMETHICONEChain Drug Marketing Association Inc.17e181e5-6527-54d0-e063-6294a90addc22024-08-23WarningsExact identifier
unii: 92RU3N3Y1O
QUALITY CHOICE Maximum Strength Gas Relief SoftgelSIMETHICONEChain Drug Marketing Association, Inc.462fdb9a-d685-4772-9233-6c43db9382cc2024-08-16WarningsExact identifier
unii: 92RU3N3Y1O
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
ClobazamCLOBAZAMUpsher-Smith Laboratories, LLC6da2c381-057b-456a-b57b-464f8b3833712024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2MRO291B4U
Anti Diarrheal Anti GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEKroger Company9c7db942-c8cb-493a-a96f-452b8dfebfc62024-07-23WarningsExact identifier
unii: 92RU3N3Y1O
signature care anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONESafeway53829e72-d22c-434d-a108-1972081a6efb2024-07-22WarningsExact identifier
unii: 92RU3N3Y1O
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

Reported adverse events (FAERS/openFDA)#

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