Home NDC 30698-455 RALDESY
Product NDC 30698-455
11-digit product format 306980455
Labeler code 30698
Product ID 30698-455_490e0fcd-3542-c976-e063-6294a90ac2ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRAZODONE HYDROCHLORIDE ORAL
Dosage form SOLUTION
Route ORAL
Labeler Validus Pharmaceuticals LLC
Application NDA218637
Marketing category NDA
Marketing start 2024-11-26
Substance TRAZODONE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218637-001 RALDESY TRAZODONE HYDROCHLORIDE 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N218637-001 RALDESY 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RALDESY TM TRAZODONE HYDROCHLORIDE ORAL Validus Pharmaceuticals LLC 34708cc1-b0b2-4fd0-b9f3-7f008b457fc9 2026-01-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 218637 application number: NDA218637 ndc (product): 30698-455
Additional Listing Data#
Finished product Yes
Brand name base RALDESY
Brand name suffix TM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAZODONE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6E8ZO8LRNM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856381 Internal RxNorm lookup 2699618 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 30698-455-01 RALDESYTM 300 mL in 1 BOTTLE SOLUTION 300 4 30698-455-02 RALDESYTM 150 mL in 1 BOTTLE SOLUTION 150 4 30698-455-03 RALDESYTM 150 mL in 1 BOTTLE, GLASS SOLUTION 150 4 30698-455-04 RALDESYTM 300 mL in 1 BOTTLE, GLASS SOLUTION 300 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30698-455 RALDESY TM (TRAZODONE HYDROCHLORIDE ORAL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 3 Current NDC, 4 package rows 20250406_34708cc1-b0b2-4fd0-b9f3-7f008b457fc9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 30698-455-01 30698045501 300 mL in 1 BOTTLE (30698-455-01) 300 ml 2024-11-26 No No Current 30698-455-02 30698045502 150 mL in 1 BOTTLE (30698-455-02) 150 ml 2024-11-26 No No Current 30698-455-03 30698045503 150 mL in 1 BOTTLE, GLASS (30698-455-03) 150 ml 2024-11-26 No No Current 30698-455-04 30698045504 300 mL in 1 BOTTLE, GLASS (30698-455-04) 300 ml 2024-11-26 No No Current