Clonazepam

Product NDC
0228-3005
11-digit product format
002283005
Labeler code
0228
Product ID
0228-3005_9e152139-3fcf-4c44-b9b2-7110cde04d12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074869
Marketing category
ANDA
Marketing start
1997-02-12
Marketing end
2022-01-31
Substance
CLONAZEPAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8e2a02d-e7b1-29aa-eb39-98a679441d91Product name320190927
dc4336d1-53d4-d410-38d3-71aa2ce4749bProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-3005-11EA - Each0228-30051f634eb5-0989-4328-8dad-b527a87d319b12012-07-24
0228-3005-50EA - Each0228-30053cb65101-2a08-4349-93da-793f5d9430d512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [STAT RX USA LLC]4
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [TYA PHARMACEUTICALS]4
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [STAT RX USA LLC]4
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [STAT RX USA LLC]4
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [STAT RX USA LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM TABLET [TYA PHARMACEUTICALS]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM TABLET [STAT RX USA LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [TYA PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [STAT RX USA LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [STAT RX USA LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [STAT RX USA LLC]4
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSNae7bbf44-c5af-4bda-bc22-2388498ad5294
197528clonazePAM 1 MG Oral TabletPSNdd29b11f-797a-4d05-a564-8d73d1ea93e04
197528clonazePAM 1 MG Oral TabletPSNae7bbf44-c5af-4bda-bc22-2388498ad5294
197529clonazePAM 2 MG Oral TabletPSNdd29b11f-797a-4d05-a564-8d73d1ea93e04
197529clonazePAM 2 MG Oral TabletPSNae7bbf44-c5af-4bda-bc22-2388498ad5294
197527clonazepam 0.5 MG Oral TabletSCDae7bbf44-c5af-4bda-bc22-2388498ad5294
197528clonazepam 1 MG Oral TabletSCDdd29b11f-797a-4d05-a564-8d73d1ea93e04
197528clonazepam 1 MG Oral TabletSCDae7bbf44-c5af-4bda-bc22-2388498ad5294
197529clonazepam 2 MG Oral TabletSCDdd29b11f-797a-4d05-a564-8d73d1ea93e04
197529clonazepam 2 MG Oral TabletSCDae7bbf44-c5af-4bda-bc22-2388498ad5294
197527clonazePAM 0.5 MG Oral TabletPSNa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197528clonazePAM 1 MG Oral TabletPSNa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197529clonazePAM 2 MG Oral TabletPSNa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197527clonazepam 0.5 MG Oral TabletSCDa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197528clonazepam 1 MG Oral TabletSCDa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197529clonazepam 2 MG Oral TabletSCDa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197527clonazePAM 0.5 MG Oral TabletPSN52a03dbc-0510-40ec-8a33-15bf1c4046221
197527clonazePAM 0.5 MG Oral TabletPSNec0e596c-baca-417d-8aa4-a1878100064d1
197528clonazePAM 1 MG Oral TabletPSN52a03dbc-0510-40ec-8a33-15bf1c4046221
197528clonazePAM 1 MG Oral TabletPSNec0e596c-baca-417d-8aa4-a1878100064d1
197529clonazePAM 2 MG Oral TabletPSN52a03dbc-0510-40ec-8a33-15bf1c4046221
197529clonazePAM 2 MG Oral TabletPSNec0e596c-baca-417d-8aa4-a1878100064d1
197527clonazepam 0.5 MG Oral TabletSCD52a03dbc-0510-40ec-8a33-15bf1c4046221
197527clonazepam 0.5 MG Oral TabletSCDec0e596c-baca-417d-8aa4-a1878100064d1
197528clonazepam 1 MG Oral TabletSCD52a03dbc-0510-40ec-8a33-15bf1c4046221
197528clonazepam 1 MG Oral TabletSCDec0e596c-baca-417d-8aa4-a1878100064d1
197529clonazepam 2 MG Oral TabletSCD52a03dbc-0510-40ec-8a33-15bf1c4046221
197529clonazepam 2 MG Oral TabletSCDec0e596c-baca-417d-8aa4-a1878100064d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-3005-1100228300511100 TABLET in 1 BOTTLE (0228-3005-11) 100 tablet1997-02-122021-06-30NoNoCurrent
0228-3005-5000228300550500 TABLET in 1 BOTTLE (0228-3005-50) 500 tablet1997-02-122022-01-31NoNoCurrent