Temazepam
Temazepam Capsules, USP Novel Laboratories, Inc. Rx only
Approved
Approval ID
85327378-86a3-4448-9185-e20bb20ebf45
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2012
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
Products 4
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 Code40032-120
Application NumberANDA071457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2012
FDA Product Classification
INGREDIENTS (14)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TEMAZEPAMActive
Quantity: 7.5 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
Temazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-123
Application NumberANDA071457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2012
FDA Product Classification
INGREDIENTS (14)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TEMAZEPAMActive
Quantity: 30 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
Temazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-122
Application NumberANDA071457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2012
FDA Product Classification
INGREDIENTS (16)
TEMAZEPAMActive
Quantity: 22.5 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Temazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-121
Application NumberANDA071456
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2012
FDA Product Classification
INGREDIENTS (16)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TEMAZEPAMActive
Quantity: 15 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT