Clonazepam

Product NDC
68071-5247
11-digit product format
680715247
Labeler code
68071
Product ID
68071-5247_1d78bc6e-79b7-c6be-e063-6394a90a18f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077147
Marketing category
ANDA
Marketing start
2011-06-03
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONAZEPAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PE9FDE8GB
Rxcui197528

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
68071-5247-92022-02-07C16284748780-1d6a99b39-7054-a426-e053-dadaa90af4c2Clonazepam Tablets, USP CIV Rx only
68071-5247-92022-01-28C16284748780-1d6a99b39-7054-a426-e053-dadaa90af4c2Clonazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5247-9Clonazepam90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5247CLONAZEPAM TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240719_a4882077-694d-d46c-e053-2a95a90a217d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSNa4882077-694d-d46c-e053-2a95a90a217d3
197528clonazepam 1 MG Oral TabletSCDa4882077-694d-d46c-e053-2a95a90a217d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5247-96807152470990 TABLET in 1 BOTTLE (68071-5247-9) 90 tablet2020-04-300000-00-00NoNoCurrent