oxazepam

Generic: oxazepam

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxazepam
Generic Name oxazepam
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

oxazepam 15 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-639
Product ID 71610-639_7aebd188-6319-41ca-950d-352ced2eeb19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071026
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610639
Hyphenated Format 71610-639

Supplemental Identifiers

RxCUI
312134
UNII
6GOW6DWN2A
NUI
N0000175694 M0002356

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oxazepam (source: ndc)
Generic Name oxazepam (source: ndc)
Application Number ANDA071026 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-639-30)
  • 60 CAPSULE in 1 BOTTLE (71610-639-53)
  • 90 CAPSULE in 1 BOTTLE (71610-639-60)
source: ndc

Packages (3)

71610-639-30 30 CAPSULE in 1 BOTTLE (71610-639-30) 71610-639-53 60 CAPSULE in 1 BOTTLE (71610-639-53) 71610-639-60 90 CAPSULE in 1 BOTTLE (71610-639-60)

Ingredients (1)

oxazepam (15 mg/1)

Linked Drug Pages (1)

Oxazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7aebd188-6319-41ca-950d-352ced2eeb19", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["6GOW6DWN2A"], "rxcui": ["312134"], "spl_set_id": ["f1e50d01-f529-4894-97d4-0af680a8b461"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-639-30)", "package_ndc": "71610-639-30", "marketing_start_date": "20220309"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-639-53)", "package_ndc": "71610-639-53", "marketing_start_date": "20220309"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-639-60)", "package_ndc": "71610-639-60", "marketing_start_date": "20220309"}], "brand_name": "Oxazepam", "product_id": "71610-639_7aebd188-6319-41ca-950d-352ced2eeb19", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-639", "dea_schedule": "CIV", "generic_name": "Oxazepam", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxazepam", "active_ingredients": [{"name": "OXAZEPAM", "strength": "15 mg/1"}], "application_number": "ANDA071026", "marketing_category": "ANDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}