FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
70518-3290
11-digit product format
705183290
Labeler code
70518
Product ID
70518-3290_509cbe82-61a0-1f1b-e063-6294a90a3850
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205253
Marketing category
ANDA
Marketing start
2020-12-13
Marketing end
2028-12-31
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856377

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525eProduct name120250730
b2f15d64-48ea-ba98-af5c-91f410667b31Product name520250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3290-02023-03-23C16284748780-1f386c64a-1621-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
70518-3290-02023-01-30C16284748780-1f386c64a-1621-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3290-0Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET3011
70518-3290-1Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET3011
70518-3290-2Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET3011
70518-3290-3Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9011
70518-3290-4Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9011
70518-3290-5Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3290TRAZODONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 6 package rows20250327_a31d59ed-5949-4f85-8b73-3bfd7f72d5b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSNa31d59ed-5949-4f85-8b73-3bfd7f72d5b811
856377trazodone hydrochloride 50 MG Oral TabletSCDa31d59ed-5949-4f85-8b73-3bfd7f72d5b811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3290-07051832900030 TABLET in 1 BLISTER PACK (70518-3290-0) 30 tablet2021-12-130000-00-00NoNoCurrent
70518-3290-17051832900130 in 1 BLISTER PACKHistorical
70518-3290-27051832900230 in 1 BLISTER PACKHistorical
70518-3290-37051832900390 in 1 BOTTLE, PLASTICHistorical
70518-3290-47051832900490 TABLET in 1 BOTTLE, PLASTIC (70518-3290-4) 90 tablet2024-05-152028-12-31NoNoHistorical
70518-3290-57051832900530 TABLET in 1 BOTTLE, PLASTIC (70518-3290-5) 30 tablet2025-03-242028-12-31NoNoHistorical