Clonazepam
Approved
Approval ID
26b1d362-e727-49db-9e81-ee80ca97795c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-6224
Application NumberANDA077171
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2011
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CLONAZEPAMActive
Quantity: 0.25 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT