CLONAZEPAM

Product NDC
61919-058
11-digit product format
619190058
Labeler code
61919
Product ID
61919-058_9238dd6e-c8f4-7e00-e053-2a95a90afd4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLONAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA074869
Marketing category
ANDA
Marketing start
2014-01-01
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
61919-058-302023-01-30C16284748780-1f386c649-db69-0266-e053-dadaa90a7c1aCLONAZEPAM
61919-058-602023-01-30C16284748780-1f386c649-db69-0266-e053-dadaa90a7c1aCLONAZEPAM
61919-058-902023-01-30C16284748780-1f386c649-db69-0266-e053-dadaa90a7c1aCLONAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-058-30CLONAZEPAM30 in 1 BOTTLETABLET305
61919-058-60CLONAZEPAM60 in 1 BOTTLETABLET605
61919-058-90CLONAZEPAM90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-058-30EA - Each61919-0586166b00c-67e2-41ca-b367-2b9012642db812014-05-02
61919-058-60EA - Each61919-058f4e1c2b1-45ca-4360-9abc-734b7d989ce112015-11-12
61919-058-90EA - Each61919-05821ad6701-a8a0-4ced-8c25-14b2ebb99f7112015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [DIRECT RX]4
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [DIRECT RX]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [DIRECT RX]4
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [DIRECT RX]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [DIRECT RX]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-058CLONAZEPAM TABLET [DIRECT RX]5Legacy NDC, 3 package rows20190911_7c335bb0-14ae-4eec-b093-f922130afb1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN7c335bb0-14ae-4eec-b093-f922130afb1f5
197527clonazepam 0.5 MG Oral TabletSCD7c335bb0-14ae-4eec-b093-f922130afb1f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-058-306191900583030 TABLET in 1 BOTTLE (61919-058-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-058-606191900586060 TABLET in 1 BOTTLE (61919-058-60) 60 tablet2014-01-010000-00-00NoNoCurrent
61919-058-906191900589090 TABLET in 1 BOTTLE (61919-058-90) 90 tablet2014-01-010000-00-00NoNoCurrent