FDA.reportPublic FDA data

Clonazepam

Product NDC
43547-406
11-digit product format
435470406
Labeler code
43547
Product ID
43547-406_dc17b9d4-2890-4f6c-8476-daa39d0cbc9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare LLC
Application
ANDA077856
Marketing category
ANDA
Marketing start
2018-02-15
Substance
CLONAZEPAM
Active strength
.5 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
CLONAZEPAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PE9FDE8GB
Rxcui197527, 197528, 197529

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
43547-406-10Clonazepam100 in 1 BOTTLE, PLASTICTABLET1009
43547-406-11Clonazepam1000 in 1 BOTTLE, PLASTICTABLET10009
43547-406-50Clonazepam500 in 1 BOTTLE, PLASTICTABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-406-10EA - Each43547-4068d92cc97-cfae-4908-ba5e-6a4547a7720e12018-03-08
43547-406-11EA - Each43547-406dfe46156-f1f5-4277-8f61-2939c126ae0d12018-03-08
43547-406-50EA - Each43547-406fd59175e-e5ea-4a5c-b244-a6d1ea851fd312018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-406CLONAZEPAM TABLET [SOLCO HEALTHCARE LLC]7Current NDC, Legacy NDC, 3 package rows20230506_4acbb7a9-4db5-4497-b8db-9f358b3f6fb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN96518266-8f75-4301-b8fd-d2995a7f486d105
197527clonazepam 0.5 MG Oral TabletSCD96518266-8f75-4301-b8fd-d2995a7f486d105
197527clonazePAM 0.5 MG Oral TabletPSNb12661a6-2141-42a9-bcb0-c0aef81395ce103
197527clonazepam 0.5 MG Oral TabletSCDb12661a6-2141-42a9-bcb0-c0aef81395ce103
197527clonazePAM 0.5 MG Oral TabletPSNd732be07-6eb7-48f2-b6cd-28baad46aca5102
197527clonazePAM 0.5 MG Oral TabletPSNcd364371-d2af-4cb4-a5df-3d3149580e16102
197527clonazePAM 0.5 MG Oral TabletPSN6960e994-e9ea-4a4a-b674-7e6124d8b381102
197527clonazepam 0.5 MG Oral TabletSCDd732be07-6eb7-48f2-b6cd-28baad46aca5102
197527clonazepam 0.5 MG Oral TabletSCDcd364371-d2af-4cb4-a5df-3d3149580e16102
197527clonazepam 0.5 MG Oral TabletSCD6960e994-e9ea-4a4a-b674-7e6124d8b381102
197527clonazePAM 0.5 MG Oral TabletPSN08d0a109-3307-47b5-8ff2-c0ad83e66f089
197527clonazePAM 0.5 MG Oral TabletPSN4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197528clonazePAM 1 MG Oral TabletPSN4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197529clonazePAM 2 MG Oral TabletPSN4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197527clonazepam 0.5 MG Oral TabletSCD4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197527clonazepam 0.5 MG Oral TabletSCD08d0a109-3307-47b5-8ff2-c0ad83e66f089
197528clonazepam 1 MG Oral TabletSCD4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197529clonazepam 2 MG Oral TabletSCD4acbb7a9-4db5-4497-b8db-9f358b3f6fb49
197527clonazePAM 0.5 MG Oral TabletPSN34366dd2-432c-4fa9-8fab-832cca781b846
197528clonazePAM 1 MG Oral TabletPSN34366dd2-432c-4fa9-8fab-832cca781b846
197527clonazepam 0.5 MG Oral TabletSCD34366dd2-432c-4fa9-8fab-832cca781b846
197528clonazepam 1 MG Oral TabletSCD34366dd2-432c-4fa9-8fab-832cca781b846
197527clonazePAM 0.5 MG Oral TabletPSN939dee35-3987-4ce2-9985-3751ceffa20e4
197527clonazePAM 0.5 MG Oral TabletPSNa821f647-be5f-274c-e053-2a95a90a23ce4
197527clonazepam 0.5 MG Oral TabletSCD939dee35-3987-4ce2-9985-3751ceffa20e4
197527clonazepam 0.5 MG Oral TabletSCDa821f647-be5f-274c-e053-2a95a90a23ce4
197527clonazePAM 0.5 MG Oral TabletPSNf2662808-01c4-330c-e053-2a95a90aa3353
197527clonazePAM 0.5 MG Oral TabletPSNc13297e2-ae3e-4198-b7c8-55fd672436aa3
197527clonazePAM 0.5 MG Oral TabletPSN66bf60fa-61ac-47a7-a081-36077af9007e3
197528clonazePAM 1 MG Oral TabletPSNc13297e2-ae3e-4198-b7c8-55fd672436aa3
197528clonazePAM 1 MG Oral TabletPSNf2662808-01c4-330c-e053-2a95a90aa3353
197529clonazePAM 2 MG Oral TabletPSNf2662808-01c4-330c-e053-2a95a90aa3353
197527clonazepam 0.5 MG Oral TabletSCDc13297e2-ae3e-4198-b7c8-55fd672436aa3
197527clonazepam 0.5 MG Oral TabletSCD66bf60fa-61ac-47a7-a081-36077af9007e3
197527clonazepam 0.5 MG Oral TabletSCDf2662808-01c4-330c-e053-2a95a90aa3353
197528clonazepam 1 MG Oral TabletSCDc13297e2-ae3e-4198-b7c8-55fd672436aa3
197528clonazepam 1 MG Oral TabletSCDf2662808-01c4-330c-e053-2a95a90aa3353
197529clonazepam 2 MG Oral TabletSCDf2662808-01c4-330c-e053-2a95a90aa3353
197527clonazePAM 0.5 MG Oral TabletPSN645fb912-479c-46de-b99c-4ea341bfd9ba1
197527clonazepam 0.5 MG Oral TabletSCD645fb912-479c-46de-b99c-4ea341bfd9ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-406-1043547040610100 TABLET in 1 BOTTLE, PLASTIC (43547-406-10) 100 tablet2018-02-150000-00-00NoNoCurrent
43547-406-11435470406111000 TABLET in 1 BOTTLE, PLASTIC (43547-406-11) 1000 tablet2018-02-150000-00-00NoNoCurrent
43547-406-5043547040650500 TABLET in 1 BOTTLE, PLASTIC (43547-406-50) 500 tablet2018-02-150000-00-00NoNoCurrent