FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
71335-3022
11-digit product format
713353022
Labeler code
71335
Product ID
71335-3022_444e384e-55aa-4354-822b-167fcba6ea0b
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRAZODONE HYDROCHLORIDE
Listing expiration
2026-12-31

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
71335-3022-2TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET30100
71335-3022-3TRAZODONE HYDROCHLORIDE90 in 1 BOTTLETABLET90100
71335-3022-4TRAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET1000100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3022-2EA - Each71335-3022880a6813-d882-4041-a8f1-e0778542249712026-01-08
71335-3022-3EA - Each71335-3022fff363ae-69b1-4a70-8101-871a0660d3f612026-01-08
71335-3022-4EA - Each71335-3022aec55779-6c93-4315-ad29-58a8e1f4b71812026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNfdd35113-5f51-49c5-a29c-ffdddd28ef38100
856373trazodone hydrochloride 100 MG Oral TabletSCDfdd35113-5f51-49c5-a29c-ffdddd28ef38100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3022-27133530220230 TABLET in 1 BOTTLE (71335-3022-2) 30 tablet2025-12-04NoNoHistorical
71335-3022-37133530220390 TABLET in 1 BOTTLE (71335-3022-3) 90 tablet2025-12-04NoNoHistorical
71335-3022-4713353022041000 TABLET in 1 BOTTLE (71335-3022-4) 1000 tablet2025-12-04NoNoHistorical