FDA.reportPublic FDA data

Clonazepam

Product NDC
71610-039
11-digit product format
716100039
Labeler code
71610
Product ID
71610-039_2343727e-d408-e54a-e063-6394a90a3142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077147
Marketing category
ANDA
Marketing start
2011-06-03
Substance
CLONAZEPAM
Active strength
.5 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
CLONAZEPAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PE9FDE8GB
Rxcui197527

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-039-45Clonazepam45 in 1 BOTTLE, PLASTICTABLET452
71610-039-53Clonazepam60 in 1 BOTTLE, PLASTICTABLET602
71610-039-60Clonazepam90 in 1 BOTTLE, PLASTICTABLET902
71610-039-70Clonazepam120 in 1 BOTTLE, PLASTICTABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-039-45EA - Each71610-039aa617865-079c-4b54-b8ea-d5d072aacfa712018-04-19
71610-039-53EA - Each71610-039eb7579cb-cd10-4c16-b381-ce799b39a6a412018-04-19
71610-039-60EA - Each71610-039fe164169-a92d-4247-bfb5-2e413604649a12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-039CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 4 package rows20241001_7b0d716c-8f51-47a7-8bf2-07c6f9732a05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN7b0d716c-8f51-47a7-8bf2-07c6f9732a052
197527clonazepam 0.5 MG Oral TabletSCD7b0d716c-8f51-47a7-8bf2-07c6f9732a052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-039-457161000394545 TABLET in 1 BOTTLE, PLASTIC (71610-039-45) 45 tablet2018-02-140000-00-00NoNoCurrent
71610-039-537161000395360 TABLET in 1 BOTTLE, PLASTIC (71610-039-53) 60 tablet2018-02-140000-00-00NoNoCurrent
71610-039-607161000396090 TABLET in 1 BOTTLE, PLASTIC (71610-039-60) 90 tablet2018-02-140000-00-00NoNoCurrent
71610-039-7071610003970120 TABLET in 1 BOTTLE, PLASTIC (71610-039-70) 120 tablet2024-09-27NoNoCurrent