Clonazepam
Clonazepam Orally Disintegrating Tablets, USP
Approved
Approval ID
1aef0069-80ea-483d-ac70-c8d485462c5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2024
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clonazepam
PRODUCT DETAILS
NDC Product Code49884-310
Application NumberANDA077171
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2024
Generic Nameclonazepam
INGREDIENTS (9)
CLONAZEPAMActive
Quantity: 2 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
clonazepam
PRODUCT DETAILS
NDC Product Code49884-309
Application NumberANDA077171
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2024
Generic Nameclonazepam
INGREDIENTS (9)
CLONAZEPAMActive
Quantity: 1 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
clonazepam
PRODUCT DETAILS
NDC Product Code49884-308
Application NumberANDA077171
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2024
Generic Nameclonazepam
INGREDIENTS (9)
CLONAZEPAMActive
Quantity: .5 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
clonazepam
PRODUCT DETAILS
NDC Product Code49884-306
Application NumberANDA077171
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2024
Generic Nameclonazepam
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CLONAZEPAMActive
Quantity: 0.125 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
clonazepam
PRODUCT DETAILS
NDC Product Code49884-307
Application NumberANDA077171
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2024
Generic Nameclonazepam
INGREDIENTS (9)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CLONAZEPAMActive
Quantity: .25 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT