FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
71335-3112
11-digit product format
713353112
Labeler code
71335
Product ID
71335-3112_56e6b3ed-ecc8-486c-8ef0-d4e474553c27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAZODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204852
Marketing category
ANDA
Marketing start
2015-09-15
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRAZODONE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856364

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3112-1TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET301
71335-3112-2TRAZODONE HYDROCHLORIDE60 in 1 BOTTLETABLET601
71335-3112-3TRAZODONE HYDROCHLORIDE90 in 1 BOTTLETABLET901
71335-3112-4TRAZODONE HYDROCHLORIDE18 in 1 BOTTLETABLET181
71335-3112-5TRAZODONE HYDROCHLORIDE100 in 1 BOTTLETABLET1001
71335-3112-6TRAZODONE HYDROCHLORIDE45 in 1 BOTTLETABLET451
71335-3112-7TRAZODONE HYDROCHLORIDE180 in 1 BOTTLETABLET1801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN34986e81-da05-46c1-8dd6-1dd7a8d1a44f1
856364trazodone hydrochloride 150 MG Oral TabletSCD34986e81-da05-46c1-8dd6-1dd7a8d1a44f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3112-17133531120130 TABLET in 1 BOTTLE (71335-3112-1) 30 tablet2026-03-30NoNoHistorical
71335-3112-27133531120260 TABLET in 1 BOTTLE (71335-3112-2) 60 tablet2026-03-30NoNoHistorical
71335-3112-37133531120390 TABLET in 1 BOTTLE (71335-3112-3) 90 tablet2026-03-30NoNoHistorical
71335-3112-47133531120418 TABLET in 1 BOTTLE (71335-3112-4) 18 tablet2026-03-30NoNoHistorical
71335-3112-571335311205100 TABLET in 1 BOTTLE (71335-3112-5) 100 tablet2026-03-30NoNoHistorical
71335-3112-67133531120645 TABLET in 1 BOTTLE (71335-3112-6) 45 tablet2026-03-30NoNoHistorical
71335-3112-771335311207180 TABLET in 1 BOTTLE (71335-3112-7) 180 tablet2026-03-30NoNoHistorical