oxazepam

Generic: oxazepam

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxazepam
Generic Name oxazepam
Labeler leading pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

oxazepam 10 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-911
Product ID 69315-911_708e4237-a898-4d23-90b1-253c18301884
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218261
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-07-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315911
Hyphenated Format 69315-911

Supplemental Identifiers

RxCUI
198057 198059 312134
UPC
0369315913017
UNII
6GOW6DWN2A
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

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 ANDA218261 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (69315-911-01)
source: ndc

Packages (1)

69315-911-01 100 CAPSULE in 1 BOTTLE (69315-911-01)

Ingredients (1)

oxazepam (10 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": "708e4237-a898-4d23-90b1-253c18301884", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0369315913017"], "unii": ["6GOW6DWN2A"], "rxcui": ["198057", "198059", "312134"], "spl_set_id": ["67f821fa-5663-4d69-82c9-5ee13a09f324"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (69315-911-01)", "package_ndc": "69315-911-01", "marketing_start_date": "20250709"}], "brand_name": "OXAZEPAM", "product_id": "69315-911_708e4237-a898-4d23-90b1-253c18301884", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "69315-911", "dea_schedule": "CIV", "generic_name": "OXAZEPAM", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXAZEPAM", "active_ingredients": [{"name": "OXAZEPAM", "strength": "10 mg/1"}], "application_number": "ANDA218261", "marketing_category": "ANDA", "marketing_start_date": "20250709", "listing_expiration_date": "20261231"}