FDA.reportPublic FDA data

Clonazepam

Product NDC
71335-1843
11-digit product format
713351843
Labeler code
71335
Product ID
71335-1843_de60045d-eb54-4f61-ad0a-1deb16c537b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077856
Marketing category
ANDA
Marketing start
2018-02-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1843-0Clonazepam100 in 1 BOTTLE, PLASTICTABLET100103
71335-1843-1Clonazepam20 in 1 BOTTLE, PLASTICTABLET20103
71335-1843-2Clonazepam30 in 1 BOTTLE, PLASTICTABLET30103
71335-1843-3Clonazepam60 in 1 BOTTLE, PLASTICTABLET60103
71335-1843-4Clonazepam90 in 1 BOTTLE, PLASTICTABLET90103
71335-1843-5Clonazepam120 in 1 BOTTLE, PLASTICTABLET120103
71335-1843-6Clonazepam180 in 1 BOTTLE, PLASTICTABLET180103
71335-1843-7Clonazepam84 in 1 BOTTLE, PLASTICTABLET84103
71335-1843-8Clonazepam28 in 1 BOTTLE, PLASTICTABLET28103
71335-1843-9Clonazepam56 in 1 BOTTLE, PLASTICTABLET56103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1843-2EA - Each71335-1843da0862d8-36df-4d2e-a1e7-b22ab093d81f12024-09-09
71335-1843-3EA - Each71335-1843a1f9655d-f786-41cc-9e5e-a0e64672459912024-09-09
71335-1843-4EA - Each71335-18434b9685ac-85b7-4162-9055-f29a478ee9e712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1843CLONAZEPAM TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240824_b83009c2-26ed-45fa-819e-164cdac264e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSNb83009c2-26ed-45fa-819e-164cdac264e6103
197528clonazepam 1 MG Oral TabletSCDb83009c2-26ed-45fa-819e-164cdac264e6103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1843-071335184300100 TABLET in 1 BOTTLE, PLASTIC (71335-1843-0) 100 tablet2021-04-290000-00-00NoNoCurrent
71335-1843-17133518430120 TABLET in 1 BOTTLE, PLASTIC (71335-1843-1) 20 tablet2021-04-290000-00-00NoNoCurrent
71335-1843-27133518430230 TABLET in 1 BOTTLE, PLASTIC (71335-1843-2) 30 tablet2021-04-290000-00-00NoNoCurrent
71335-1843-37133518430360 TABLET in 1 BOTTLE, PLASTIC (71335-1843-3) 60 tablet2021-04-290000-00-00NoNoCurrent
71335-1843-47133518430490 TABLET in 1 BOTTLE, PLASTIC (71335-1843-4) 90 tablet2021-04-290000-00-00NoNoCurrent
71335-1843-571335184305120 TABLET in 1 BOTTLE, PLASTIC (71335-1843-5) 120 tablet2021-04-290000-00-00NoNoCurrent
71335-1843-671335184306180 TABLET in 1 BOTTLE, PLASTIC (71335-1843-6) 180 tablet2021-04-290000-00-00NoNoCurrent
71335-1843-77133518430784 TABLET in 1 BOTTLE, PLASTIC (71335-1843-7) 84 tablet2021-04-290000-00-00NoNoCurrent
71335-1843-87133518430828 TABLET in 1 BOTTLE, PLASTIC (71335-1843-8) 28 tablet2021-04-290000-00-00NoNoCurrent
71335-1843-97133518430956 TABLET in 1 BOTTLE, PLASTIC (71335-1843-9) 56 tablet2021-04-290000-00-00NoNoCurrent