FDA.reportPublic FDA data

Clonazepam

Product NDC
70518-3960
11-digit product format
705183960
Labeler code
70518
Product ID
70518-3960_4c5c80ef-2f51-5b34-e063-6394a90ae182
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075150
Marketing category
ANDA
Marketing start
2023-12-13
Substance
CLONAZEPAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2027-12-31

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
70518-3960-0Clonazepam100 in 1 BOXTABLET1007
70518-3960-1Clonazepam1 in 1 POUCHTABLET17
70518-3960-2Clonazepam30 in 1 BLISTER PACKTABLET307
70518-3960-3Clonazepam30 in 1 BLISTER PACKTABLET307
70518-3960-4Clonazepam30 in 1 BOTTLE, PLASTICTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3960CLONAZEPAM TABLET [REMEDYREPACK INC.]5Current NDC, 5 package rows20250502_1fb0807c-dccd-47a5-ada4-91418c4f47f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN1fb0807c-dccd-47a5-ada4-91418c4f47f57
197527clonazepam 0.5 MG Oral TabletSCD1fb0807c-dccd-47a5-ada4-91418c4f47f57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3960-070518396000100 POUCH in 1 BOX (70518-3960-0) / 1 TABLET in 1 POUCH (70518-3960-1) 100 pouch2023-12-13NoNoHistorical
70518-3960-1705183960011 in 1 POUCHHistorical
70518-3960-27051839600230 in 1 BLISTER PACKHistorical
70518-3960-37051839600330 TABLET in 1 BLISTER PACK (70518-3960-3) 30 tablet2024-09-10NoNoHistorical
70518-3960-47051839600430 TABLET in 1 BOTTLE, PLASTIC (70518-3960-4) 30 tablet2025-06-17NoNoHistorical