Oxazepam
Oxazepam Capsules, USP
Approved
Approval ID
a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0228-2069
Application NumberANDA072253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (19)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXAZEPAMActive
Quantity: 15 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
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 Code0228-2067
Application NumberANDA072253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (19)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OXAZEPAMActive
Quantity: 10 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Oxazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0228-2073
Application NumberANDA072253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (17)
OXAZEPAMActive
Quantity: 30 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT