Temazepam
Temazepam Capsules, USP Rx only
Approved
Approval ID
93b1be7f-ec41-46bb-a258-56cb459e2c92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 20, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-381
Application NumberANDA211542
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2023
FDA Product Classification
INGREDIENTS (14)
TEMAZEPAMActive
Quantity: 22.5 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Temazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-382
Application NumberANDA211542
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2023
FDA Product Classification
INGREDIENTS (15)
TEMAZEPAMActive
Quantity: 30 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Temazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-380
Application NumberANDA211542
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2023
FDA Product Classification
INGREDIENTS (14)
TEMAZEPAMActive
Quantity: 15 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Temazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-379
Application NumberANDA211542
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2023
FDA Product Classification
INGREDIENTS (15)
TEMAZEPAMActive
Quantity: 7.5 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT