Oxazepam
OXAZEPAM CAPSULES, USP
Approved
Approval ID
3bccbfa9-fdcf-44c3-86f5-028ca92223ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 2
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 Code67544-268
Application NumberANDA072252
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2014
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
OXAZEPAMActive
Quantity: 15 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Oxazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67544-117
Application NumberANDA072251
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2014
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXAZEPAMActive
Quantity: 10 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT