Clonazepam

Product NDC
45865-575
11-digit product format
458650575
Labeler code
45865
Product ID
45865-575_9ab32ff5-aff0-2d1f-e053-2a95a90a592b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA074869
Marketing category
ANDA
Marketing start
2009-02-13
Marketing end
0000-00-00
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8e2a02d-e7b1-29aa-eb39-98a679441d91Product name320190927
dc4336d1-53d4-d410-38d3-71aa2ce4749bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-575-302025-01-30C16284748780-12cef2736-78de-d83d-e063-dadaa90ab31fCLONAZEPAM TABLETS, USP
45865-575-602025-01-30C16284748780-12cef2736-78de-d83d-e063-dadaa90ab31fCLONAZEPAM TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-575-30Clonazepam30 in 1 BOTTLETABLET302
45865-575-60Clonazepam60 in 1 BOTTLETABLET602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]1
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-575CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_1edec3f0-b6c9-1c0f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN1edec3f0-b6c9-1c0f-e054-00144ff8d46c2
197527clonazepam 0.5 MG Oral TabletSCD1edec3f0-b6c9-1c0f-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-575-304586505753030 TABLET in 1 BOTTLE (45865-575-30) 30 tablet2015-09-030000-00-00NoNoCurrent
45865-575-604586505756060 TABLET in 1 BOTTLE (45865-575-60) 60 tablet2015-09-030000-00-00NoNoCurrent