raldesy tm

Generic: trazodone hydrochloride oral

Labeler: validus pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name raldesy tm
Generic Name trazodone hydrochloride oral
Labeler validus pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

trazodone hydrochloride 10 mg/mL

Manufacturer
Validus Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 30698-455
Product ID 30698-455_490e0fcd-3542-c976-e063-6294a90ac2ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218637
Listing Expiration 2027-12-31
Marketing Start 2024-11-26

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 30698455
Hyphenated Format 30698-455

Supplemental Identifiers

RxCUI
856381 2699618
UPC
0330698455029 0330698455043 0330698455012
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 raldesy tm (source: ndc)
Generic Name trazodone hydrochloride oral (source: ndc)
Application Number NDA218637 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 300 mL in 1 BOTTLE (30698-455-01)
  • 150 mL in 1 BOTTLE (30698-455-02)
  • 150 mL in 1 BOTTLE, GLASS (30698-455-03)
  • 300 mL in 1 BOTTLE, GLASS (30698-455-04)
source: ndc

Packages (4)

30698-455-01 300 mL in 1 BOTTLE (30698-455-01) 30698-455-02 150 mL in 1 BOTTLE (30698-455-02) 30698-455-03 150 mL in 1 BOTTLE, GLASS (30698-455-03) 30698-455-04 300 mL in 1 BOTTLE, GLASS (30698-455-04)

Ingredients (1)

trazodone hydrochloride (10 mg/mL)

Linked Drug Pages (1)

RALDESY TM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "490e0fcd-3542-c976-e063-6294a90ac2ce", "openfda": {"upc": ["0330698455029", "0330698455043", "0330698455012"], "unii": ["6E8ZO8LRNM"], "rxcui": ["856381", "2699618"], "spl_set_id": ["34708cc1-b0b2-4fd0-b9f3-7f008b457fc9"], "manufacturer_name": ["Validus Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 mL in 1 BOTTLE (30698-455-01)", "package_ndc": "30698-455-01", "marketing_start_date": "20241126"}, {"sample": false, "description": "150 mL in 1 BOTTLE (30698-455-02)", "package_ndc": "30698-455-02", "marketing_start_date": "20241126"}, {"sample": false, "description": "150 mL in 1 BOTTLE, GLASS (30698-455-03)", "package_ndc": "30698-455-03", "marketing_start_date": "20241126"}, {"sample": false, "description": "300 mL in 1 BOTTLE, GLASS (30698-455-04)", "package_ndc": "30698-455-04", "marketing_start_date": "20241126"}], "brand_name": "RALDESY TM", "product_id": "30698-455_490e0fcd-3542-c976-e063-6294a90ac2ce", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]"], "product_ndc": "30698-455", "generic_name": "TRAZODONE HYDROCHLORIDE ORAL", "labeler_name": "Validus Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RALDESY", "brand_name_suffix": "TM", "active_ingredients": [{"name": "TRAZODONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "NDA218637", "marketing_category": "NDA", "marketing_start_date": "20241126", "listing_expiration_date": "20271231"}