FDA.reportPublic FDA data

CLONAZEPAM

Product NDC
61919-485
11-digit product format
619190485
Labeler code
61919
Product ID
61919-485_f2147684-a853-54bb-e053-2995a90a736c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLONAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077147
Marketing category
ANDA
Marketing start
2018-03-14
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
2024-12-31
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
61919-485-302025-01-30C16284748780-12cef2736-aa7d-d83d-e063-dadaa90ab31fCLONAZEPAM
61919-485-602023-01-30C16284748780-1f386c649-c2d1-0266-e053-dadaa90a7c1aCLONAZEPAM
61919-485-902023-01-30C16284748780-1f386c649-e225-0266-e053-dadaa90a7c1aCLONAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-485-30CLONAZEPAM30 in 1 BOTTLETABLET307
61919-485-60CLONAZEPAM60 in 1 BOTTLETABLET601
61919-485-90CLONAZEPAM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-485-30EA - Each61919-485cdd0672a-e173-428e-a8d0-82408d2c848a12018-04-19
61919-485-60EA - Each61919-4858a4e123a-e505-4368-941f-0f499a345eaf12019-08-06
61919-485-90EA - Each61919-485b015a47d-0f66-46fe-b18b-cff2fe61732a12019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [DIRECT RX]2
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-485CLONAZEPAM TABLET [DIRECT RX]7Legacy NDC, 1 package rows20230113_78f87e87-6d36-4ee8-9d2d-ec75666c71ce.zip
61919-485CLONAZEPAM TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190712_8d6ddd91-0397-a23b-e053-2a95a90abc83.zip
61919-485CLONAZEPAM TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190712_8d6e2f75-be76-db92-e053-2995a90ae406.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN78f87e87-6d36-4ee8-9d2d-ec75666c71ce7
197528clonazepam 1 MG Oral TabletSCD78f87e87-6d36-4ee8-9d2d-ec75666c71ce7
197528clonazePAM 1 MG Oral TabletPSN8d6ddd91-0397-a23b-e053-2a95a90abc831
197528clonazePAM 1 MG Oral TabletPSN8d6e2f75-be76-db92-e053-2995a90ae4061
197528clonazepam 1 MG Oral TabletSCD8d6ddd91-0397-a23b-e053-2a95a90abc831
197528clonazepam 1 MG Oral TabletSCD8d6e2f75-be76-db92-e053-2995a90ae4061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-485-306191904853030 TABLET in 1 BOTTLE (61919-485-30) 30 tablet2018-03-140000-00-00NoNoCurrent
61919-485-606191904856060 TABLET in 1 BOTTLE (61919-485-60) 60 tablet2019-07-110000-00-00NoNoCurrent
61919-485-906191904859090 TABLET in 1 BOTTLE (61919-485-90) 90 tablet2019-07-110000-00-00NoNoCurrent