Label: OXAZEPAM capsule

  • NDC Code(s): 52817-290-10, 52817-291-10, 52817-292-10
  • Packager: TruPharma, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 14, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • Principal Display Panel

    Oxazepam Capsules, USP

    NDC       10mg         52817-290-10

    CIV        Oxazepam Capsules, USP

          10mg

    PHARMACIST: Dispense the accompanying Medication Guide to each patient

    Rx only

    100 Capsules

    TruPharma

     Principal Display Panel
Oxazepam Capsules, USP

NDC 	10mg  	52817-290-10  
CIV 	Oxazepam Capsules, USP
	10mg 
PHARMACIST: Dispense the accompanying Medication Guide to each patient
Rx only
100 Capsules
TruPharma

  • Principal Display Panel

    NDC       15 mg 52817-291-10  

    CIV        Oxazepam Capsules, USP

          15mg

    PHARMACIST: Dispense the accompanying Medication Guide to each patient

    Rx only

    100 Capsules

    TruPharma

    NDC 	15 mg 52817-291-10  
CIV 	Oxazepam Capsules, USP
	15mg 
PHARMACIST: Dispense the accompanying Medication Guide to each patient
Rx only
100 Capsules
TruPharma

  • Principal Display Panel

    NDC       30 mg 52817-292-10

    CIV        Oxazepam Capsules, USP

          30mg

    PHARMACIST: Dispense the accompanying Medication Guide to each patient

    Rx only

    100 Capsules

    TruPharma

    NDC 	30 mg 52817-292-10
CIV 	Oxazepam Capsules, USP
	30mg 
PHARMACIST: Dispense the accompanying Medication Guide to each patient
Rx only
100 Capsules
TruPharma

  • INGREDIENTS AND APPEARANCE
    OXAZEPAM 
    oxazepam capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52817-290
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXAZEPAM (UNII: 6GOW6DWN2A) (OXAZEPAM - UNII:6GOW6DWN2A) OXAZEPAM10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code FBP660
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52817-290-10100 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07102605/15/2020
    OXAZEPAM 
    oxazepam capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52817-291
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXAZEPAM (UNII: 6GOW6DWN2A) (OXAZEPAM - UNII:6GOW6DWN2A) OXAZEPAM15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorREDScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code FBP661
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52817-291-10100 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07102605/15/2020
    OXAZEPAM 
    oxazepam capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52817-292
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXAZEPAM (UNII: 6GOW6DWN2A) (OXAZEPAM - UNII:6GOW6DWN2A) OXAZEPAM30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    ColorREDScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code FBP662
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52817-292-10100 in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07102603/19/2020
    Labeler - TruPharma, LLC (078533947)