FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
71205-574
11-digit product format
712050574
Labeler code
71205
Product ID
71205-574_82b1165a-6f2c-470c-adff-9db816fb0ad4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA071524
Marketing category
ANDA
Marketing start
2020-10-08
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
71205-574-30Trazodone Hydrochloride30 in 1 BOTTLETABLET302
71205-574-60Trazodone Hydrochloride60 in 1 BOTTLETABLET602
71205-574-90Trazodone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-574-30EA - Each71205-574dc69358c-7da9-43eb-9562-6304de62434c12021-07-15
71205-574-90EA - Each71205-574b6812906-7979-4c4f-9f02-013d31ae515612022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-574TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20230528_203881a3-37d0-41dd-86c5-1e53fb784326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN203881a3-37d0-41dd-86c5-1e53fb7843262
856373trazodone hydrochloride 100 MG Oral TabletSCD203881a3-37d0-41dd-86c5-1e53fb7843262

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-574-307120505743030 TABLET in 1 BOTTLE (71205-574-30) 30 tablet2021-06-080000-00-00NoNoCurrent
71205-574-607120505746060 TABLET in 1 BOTTLE (71205-574-60) 60 tablet2021-06-080000-00-00NoNoCurrent
71205-574-907120505749090 TABLET in 1 BOTTLE (71205-574-90) 90 tablet2021-06-080000-00-00NoNoCurrent