FDA.reportPublic FDA data

Clonazepam

Product NDC
70518-2507
11-digit product format
705182507
Labeler code
70518
Product ID
70518-2507_4e012086-11e6-3569-e063-6294a90a742c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA074569
Marketing category
ANDA
Marketing start
2019-12-26
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
70518-2507-0Clonazepam100 in 1 BOXTABLET10015
70518-2507-1Clonazepam1 in 1 POUCHTABLET115
70518-2507-2Clonazepam100 in 1 BOXTABLET10015
70518-2507-3Clonazepam1 in 1 POUCHTABLET115
70518-2507-4Clonazepam30 in 1 BLISTER PACKTABLET3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2507CLONAZEPAM TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 5 package rows20250424_b1c53213-9f84-4389-b6dc-3dc26d9a6364.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSNb1c53213-9f84-4389-b6dc-3dc26d9a636415
197527clonazepam 0.5 MG Oral TabletSCDb1c53213-9f84-4389-b6dc-3dc26d9a636415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2507-070518250700100 POUCH in 1 BOX (70518-2507-0) / 1 TABLET in 1 POUCH (70518-2507-1) 100 pouch2019-12-260000-00-00NoNoCurrent
70518-2507-1705182507011 in 1 POUCHHistorical
70518-2507-270518250702100 POUCH in 1 BOX (70518-2507-2) > 1 TABLET in 1 POUCH (70518-2507-3) 100 pouch2023-01-040000-00-00NoNoCurrent
70518-2507-3705182507031 in 1 POUCHHistorical
70518-2507-47051825070430 TABLET in 1 BLISTER PACK (70518-2507-4) 30 tablet2023-05-31NoNoCurrent