trazodone hydrochloride

Generic: trazodone hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name trazodone hydrochloride
Generic Name trazodone hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

trazodone hydrochloride 50 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-014
Product ID 57664-014_323e3d63-4d8d-7088-e063-6294a90abb0f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073137
Listing Expiration 2026-12-31
Marketing Start 2022-10-03

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664014
Hyphenated Format 57664-014

Supplemental Identifiers

RxCUI
856364 856373 856377
UPC
0357664014721
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 ANDA073137 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-72)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-74)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-75)
source: ndc

Packages (3)

57664-014-72 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-72) 57664-014-74 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-74) 57664-014-75 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-75)

Ingredients (1)

trazodone hydrochloride (50 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": "323e3d63-4d8d-7088-e063-6294a90abb0f", "openfda": {"upc": ["0357664014721"], "unii": ["6E8ZO8LRNM"], "rxcui": ["856364", "856373", "856377"], "spl_set_id": ["f291b905-a739-5e43-e053-2995a90ac40c"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-72)", "package_ndc": "57664-014-72", "marketing_start_date": "20221003"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-74)", "package_ndc": "57664-014-74", "marketing_start_date": "20221003"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-75)", "package_ndc": "57664-014-75", "marketing_start_date": "20221003"}], "brand_name": "Trazodone Hydrochloride", "product_id": "57664-014_323e3d63-4d8d-7088-e063-6294a90abb0f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]"], "product_ndc": "57664-014", "generic_name": "Trazodone Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trazodone Hydrochloride", "active_ingredients": [{"name": "TRAZODONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA073137", "marketing_category": "ANDA", "marketing_start_date": "20221003", "listing_expiration_date": "20261231"}