Oxazepam by TruPharma, LLC OXAZEPAM capsule

Oxazepam by

Drug Labeling and Warnings

Oxazepam by is a Prescription medication manufactured, distributed, or labeled by TruPharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

OXAZEPAM 
oxazepam capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52817-290
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXAZEPAM (UNII: 6GOW6DWN2A) (OXAZEPAM - UNII:6GOW6DWN2A)	OXAZEPAM	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	FBP660
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52817-290-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071026	03/19/2020

OXAZEPAM 
oxazepam capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52817-291
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXAZEPAM (UNII: 6GOW6DWN2A) (OXAZEPAM - UNII:6GOW6DWN2A)	OXAZEPAM	15 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	FBP661
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52817-291-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071026	03/19/2020

OXAZEPAM 
oxazepam capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52817-292
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXAZEPAM (UNII: 6GOW6DWN2A) (OXAZEPAM - UNII:6GOW6DWN2A)	OXAZEPAM	30 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	FBP662
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52817-292-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071026	03/19/2020

Labeler - TruPharma, LLC (078533947)