Trazodone Hydrochloride

Product NDC
0555-0711
11-digit product format
005550711
Labeler code
0555
Product ID
0555-0711_3902eb87-aa22-4775-b56a-7cb86c5f920e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA071196
Marketing category
ANDA
Marketing start
2021-12-09
Substance
TRAZODONE HYDROCHLORIDE
Active strength
300 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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856369

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
0555-0711-02Trazodone Hydrochloride100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0711-02EA - Each0555-0711607f2df7-5661-4439-810b-734635a2961112022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0711TRAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]3Current NDC, Legacy NDC, 1 package rows20221029_9c4da6ad-d4d1-4e8c-918d-8ac48512a93f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856369traZODone HCl 300 MG Oral TabletPSN9c4da6ad-d4d1-4e8c-918d-8ac48512a93f3
856369trazodone hydrochloride 300 MG Oral TabletSCD9c4da6ad-d4d1-4e8c-918d-8ac48512a93f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0711-0200555071102100 TABLET in 1 BOTTLE (0555-0711-02) 100 tablet2021-12-090000-00-00NoNoCurrent