NDC 43353-965

Oxazepam

Oxazepam

Oxazepam is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Oxazepam.

• Product ID: 43353-965_d630cdd9-fe25-4ea6-8a1f-0100bb6e6cb5
• NDC: 43353-965
• Product Type: Human Prescription Drug
• Proprietary Name: Oxazepam
• Generic Name: Oxazepam
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1988-04-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA071813
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: OXAZEPAM
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Benzodiazepine [EPC],Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43353-965-30

30 CAPSULE in 1 BOTTLE (43353-965-30)

• Marketing Start Date: 2014-10-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-965-60 [43353096560]

Oxazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071813
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-25

NDC 43353-965-53 [43353096553]

Oxazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071813
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-30

NDC 43353-965-30 [43353096530]

Oxazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071813
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-25

Drug Details

Active Ingredients

Ingredient	Strength
OXAZEPAM	10 mg/1

OpenFDA Data

• SPL SET ID: 1382470a-7eec-4e7c-aa86-15254fb57a5a
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 6GOW6DWN2A
• RxNorm Concept Unique ID - RxCUI:
  • 198057
  • 198059

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]
• Benzodiazepine [EPC]
• Benzodiazepines [CS]

NDC Crossover Matching brand name "Oxazepam" or generic name "Oxazepam"

NDC	Brand Name	Generic Name
0228-2067	Oxazepam	Oxazepam
0228-2069	Oxazepam	Oxazepam
0228-2073	Oxazepam	Oxazepam
0781-2809	Oxazepam	Oxazepam
0781-2810	Oxazepam	Oxazepam
0781-2811	Oxazepam	Oxazepam
43353-074	Oxazepam	Oxazepam
43353-965	Oxazepam	Oxazepam
43353-980	Oxazepam	Oxazepam
52817-290	Oxazepam	Oxazepam
52817-291	Oxazepam	Oxazepam
52817-292	Oxazepam	Oxazepam
62584-812	Oxazepam	Oxazepam
62584-813	Oxazepam	Oxazepam
62584-814	Oxazepam	Oxazepam
67544-294	Oxazepam	Oxazepam
67544-117	Oxazepam	Oxazepam
67544-268	Oxazepam	Oxazepam