Oxazepam
Oxazepam Capsules, USP
Approved
Approval ID
1382470a-7eec-4e7c-aa86-15254fb57a5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 21, 2016
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 Code43353-980
Application NumberANDA071814
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2014
FDA Product Classification
INGREDIENTS (13)
OXAZEPAMActive
Quantity: 30 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Oxazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-965
Application NumberANDA071813
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxazepam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2014
FDA Product Classification
INGREDIENTS (18)
OXAZEPAMActive
Quantity: 10 mg in 1 1
Code: 6GOW6DWN2A
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT