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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-310
Application NumberANDA077171
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-309
Application NumberANDA077171
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-308
Application NumberANDA077171
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-306
Application NumberANDA077171
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-307
Application NumberANDA077171
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2024
FDA Product Classification
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