Temazepam
Approved
Approval ID
55f28be9-7d69-467c-b5de-6e281ca9c498
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 8, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
temazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-651
Application NumberANDA070920
Product Classification
M
Marketing Category
C73584
G
Generic Name
temazepam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2012
FDA Product Classification
INGREDIENTS (16)
TEMAZEPAMActive
Quantity: 15 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
temazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-561
Application NumberANDA070920
Product Classification
M
Marketing Category
C73584
G
Generic Name
temazepam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2012
FDA Product Classification
INGREDIENTS (16)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TEMAZEPAMActive
Quantity: 30 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT