FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
71335-3098
11-digit product format
713353098
Labeler code
71335
Product ID
71335-3098_e5f0e257-b6a2-4c1f-abdd-be0faa9970b8
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
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856373

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
71335-3098-1TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET301
71335-3098-2TRAZODONE HYDROCHLORIDE60 in 1 BOTTLETABLET601
71335-3098-3TRAZODONE HYDROCHLORIDE90 in 1 BOTTLETABLET901
71335-3098-4TRAZODONE HYDROCHLORIDE180 in 1 BOTTLETABLET1801
71335-3098-5TRAZODONE HYDROCHLORIDE28 in 1 BOTTLETABLET281
71335-3098-6TRAZODONE HYDROCHLORIDE10 in 1 BOTTLETABLET101
71335-3098-7TRAZODONE HYDROCHLORIDE120 in 1 BOTTLETABLET1201
71335-3098-8TRAZODONE HYDROCHLORIDE45 in 1 BOTTLETABLET451
71335-3098-9TRAZODONE HYDROCHLORIDE14 in 1 BOTTLETABLET141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNdfd2698d-b7a3-49e0-aa2f-1af0ca894b351
856373trazodone hydrochloride 100 MG Oral TabletSCDdfd2698d-b7a3-49e0-aa2f-1af0ca894b351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3098-17133530980130 TABLET in 1 BOTTLE (71335-3098-1) 30 tablet2026-03-13NoNoHistorical
71335-3098-27133530980260 TABLET in 1 BOTTLE (71335-3098-2) 60 tablet2026-03-13NoNoHistorical
71335-3098-37133530980390 TABLET in 1 BOTTLE (71335-3098-3) 90 tablet2026-03-13NoNoHistorical
71335-3098-471335309804180 TABLET in 1 BOTTLE (71335-3098-4) 180 tablet2026-03-13NoNoHistorical
71335-3098-57133530980528 TABLET in 1 BOTTLE (71335-3098-5) 28 tablet2026-03-13NoNoHistorical
71335-3098-67133530980610 TABLET in 1 BOTTLE (71335-3098-6) 10 tablet2026-03-13NoNoHistorical
71335-3098-771335309807120 TABLET in 1 BOTTLE (71335-3098-7) 120 tablet2026-03-13NoNoHistorical
71335-3098-87133530980845 TABLET in 1 BOTTLE (71335-3098-8) 45 tablet2026-03-13NoNoHistorical
71335-3098-97133530980914 TABLET in 1 BOTTLE (71335-3098-9) 14 tablet2026-03-13NoNoHistorical