trazodone hydrochloride

Generic: trazodone hydrochloride

Labeler: oxford pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name trazodone hydrochloride
Generic Name trazodone hydrochloride
Labeler oxford pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

trazodone hydrochloride 100 mg/1

Manufacturer
Oxford Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69584-885
Product ID 69584-885_21124c29-b0a7-4729-90f8-0e971d265b61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072193
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69584885
Hyphenated Format 69584-885

Supplemental Identifiers

RxCUI
856373 856377
UPC
0369584885909 0369584884902
UNII
6E8ZO8LRNM

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 trazodone hydrochloride (source: ndc)
Generic Name trazodone hydrochloride (source: ndc)
Application Number ANDA072193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-50)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-90)
source: ndc

Packages (3)

69584-885-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-10) 69584-885-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-50) 69584-885-90 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-90)

Ingredients (1)

trazodone hydrochloride (100 mg/1)

Linked Drug Pages (1)

Trazodone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21124c29-b0a7-4729-90f8-0e971d265b61", "openfda": {"upc": ["0369584885909", "0369584884902"], "unii": ["6E8ZO8LRNM"], "rxcui": ["856373", "856377"], "spl_set_id": ["283c8236-9776-44cb-b7b2-1024689de736"], "manufacturer_name": ["Oxford Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-10)", "package_ndc": "69584-885-10", "marketing_start_date": "20230301"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-50)", "package_ndc": "69584-885-50", "marketing_start_date": "20230301"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-90)", "package_ndc": "69584-885-90", "marketing_start_date": "20230301"}], "brand_name": "Trazodone Hydrochloride", "product_id": "69584-885_21124c29-b0a7-4729-90f8-0e971d265b61", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]"], "product_ndc": "69584-885", "generic_name": "Trazodone Hydrochloride", "labeler_name": "Oxford Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trazodone Hydrochloride", "active_ingredients": [{"name": "TRAZODONE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA072193", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}