FDA.reportPublic FDA data

Clonazepam

Product NDC
70518-2334
11-digit product format
705182334
Labeler code
70518
Product ID
70518-2334_4a031d35-c240-c81f-e063-6394a90af142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077147
Marketing category
ANDA
Marketing start
2019-10-01
Substance
CLONAZEPAM
Active strength
1 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
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
70518-2334-0Clonazepam100 in 1 BOXTABLET10011
70518-2334-1Clonazepam1 in 1 POUCHTABLET111
70518-2334-2Clonazepam60 in 1 BOTTLE, PLASTICTABLET6011
70518-2334-3Clonazepam30 in 1 BLISTER PACKTABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2334-0EA - Each70518-233429276c5d-2e09-46fd-bcab-b6836483653b12026-01-08
70518-2334-1EA - Each70518-23345b851e59-6c0b-4b8a-906a-97c4abfc52b712026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2334CLONAZEPAM TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250426_a4185456-68f9-47d4-9952-fcdef86989db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSNa4185456-68f9-47d4-9952-fcdef86989db11
197528clonazepam 1 MG Oral TabletSCDa4185456-68f9-47d4-9952-fcdef86989db11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2334-070518233400100 POUCH in 1 BOX (70518-2334-0) / 1 TABLET in 1 POUCH (70518-2334-1) 100 pouch2019-10-010000-00-00NoNoCurrent
70518-2334-1705182334011 in 1 POUCHHistorical
70518-2334-27051823340260 TABLET in 1 BOTTLE, PLASTIC (70518-2334-2) 60 tablet2025-06-17NoNoHistorical
70518-2334-37051823340330 TABLET in 1 BLISTER PACK (70518-2334-3) 30 tablet2025-08-13NoNoHistorical