FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50268-776
11-digit product format
502680776
Labeler code
50268
Product ID
50268-776_4836a55b-859d-c6d2-e063-6294a90ae94d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA205253
Marketing category
ANDA
Marketing start
2020-02-21
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
50268-776-11Trazodone Hydrochloride1 in 1 BLISTER PACKTABLET15
50268-776-15Trazodone Hydrochloride50 in 1 BOXTABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-776-11EA - Each50268-776e3f36729-5354-4d1e-bd01-1e87e220e43a12020-03-10
50268-776-15EA - Each50268-776f4728614-65fa-4efc-b372-21418ba58a1112020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-776TRAZODONE HYDROCHLORIDE TABLET [AVPAK]4Current NDC, Legacy NDC, 2 package rows20240110_9f1c2bf1-5204-7306-e053-2a95a90a9903.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN9f1c2bf1-5204-7306-e053-2a95a90a99035
856364trazodone hydrochloride 150 MG Oral TabletSCD9f1c2bf1-5204-7306-e053-2a95a90a99035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-776-11502680776111 in 1 BLISTER PACKHistorical
50268-776-155026807761550 BLISTER PACK in 1 BOX (50268-776-15) / 1 TABLET in 1 BLISTER PACK (50268-776-11) 50 blister pack2020-02-210000-00-00NoNoCurrent