FDA.reportPublic FDA data

Clonazepam

Product NDC
63629-8988
11-digit product format
636298988
Labeler code
63629
Product ID
63629-8988_8ab8ea8e-f6f3-4b4e-9ca9-2610a70850c9
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
63629-8988-1Clonazepam30 in 1 BOTTLE, PLASTICTABLET30101
63629-8988-2Clonazepam60 in 1 BOTTLE, PLASTICTABLET60101
63629-8988-3Clonazepam90 in 1 BOTTLE, PLASTICTABLET90101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8988-1EA - Each63629-8988691ddd63-ea11-40db-ae09-c211eb8baa3d12022-03-09
63629-8988-2EA - Each63629-8988532f80e3-9ef0-49d4-add8-8e2eaee959f012022-03-09
63629-8988-3EA - Each63629-8988217d4f4b-c6c7-4972-8ecc-ebf200c9e79212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8988CLONAZEPAM TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 3 package rows20240509_5ec3df57-1137-4402-84e6-28dd76286427.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN5ec3df57-1137-4402-84e6-28dd76286427101
197528clonazepam 1 MG Oral TabletSCD5ec3df57-1137-4402-84e6-28dd76286427101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8988-16362989880130 TABLET in 1 BOTTLE, PLASTIC (63629-8988-1) 30 tablet2024-04-040000-00-00NoNoCurrent
63629-8988-26362989880260 TABLET in 1 BOTTLE, PLASTIC (63629-8988-2) 60 tablet2024-04-040000-00-00NoNoCurrent
63629-8988-36362989880390 TABLET in 1 BOTTLE, PLASTIC (63629-8988-3) 90 tablet2024-04-040000-00-00NoNoCurrent