Oxazepam
Oxazepam Capsules, USP
Approved
Approval ID
bda8bc70-3328-46f2-89d5-7ef7a061b418
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2021
Manufacturers
FDA
TruPharma, LLC
DUNS: 078533947
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-290
Application NumberANDA071026
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2021
FDA Product Classification
INGREDIENTS (17)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
OXAZEPAMActive
Quantity: 10 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Oxazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-291
Application NumberANDA071026
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2021
FDA Product Classification
INGREDIENTS (18)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
OXAZEPAMActive
Quantity: 15 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Oxazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-292
Application NumberANDA071026
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2021
FDA Product Classification
INGREDIENTS (18)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
OXAZEPAMActive
Quantity: 30 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT