Clonazepam

Product NDC
43063-788
11-digit product format
430630788
Labeler code
43063
Product ID
43063-788_414bb263-b84a-5358-e063-6294a90ad4bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077147
Marketing category
ANDA
Marketing start
2011-06-03
Substance
CLONAZEPAM
Active strength
2 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
CLONAZEPAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PE9FDE8GB
Rxcui197529

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
43063-788-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-788-30EA - Each43063-7887134745c-6d1e-4222-a26f-a63a62bd833112017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-788CLONAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 1 package rows20240608_1ce88d2c-70f7-427b-8787-4afd9ce6f71c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197529clonazePAM 2 MG Oral TabletPSN1ce88d2c-70f7-427b-8787-4afd9ce6f71c15
197529clonazepam 2 MG Oral TabletSCD1ce88d2c-70f7-427b-8787-4afd9ce6f71c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-788-304306307883030 TABLET in 1 BOTTLE, PLASTIC (43063-788-30) 30 tablet2017-09-010000-00-00NoNoCurrent