FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
70518-2973
11-digit product format
705182973
Labeler code
70518
Product ID
70518-2973_500cc85b-f3ce-8b3b-e063-6294a90afef1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071524
Marketing category
ANDA
Marketing start
2021-01-12
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
70518-2973-0Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET3013
70518-2973-1Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET3013
70518-2973-2Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9013
70518-2973-3Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2973TRAZODONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 4 package rows20250429_7bba99e5-4096-4fcb-8591-dc4a9bfe975e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN7bba99e5-4096-4fcb-8591-dc4a9bfe975e13
856373trazodone hydrochloride 100 MG Oral TabletSCD7bba99e5-4096-4fcb-8591-dc4a9bfe975e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2973-07051829730030 TABLET in 1 BLISTER PACK (70518-2973-0) 30 tablet2021-01-120000-00-00NoNoCurrent
70518-2973-17051829730130 TABLET in 1 BLISTER PACK (70518-2973-1) 30 tablet2021-01-290000-00-00NoNoCurrent
70518-2973-27051829730290 TABLET in 1 BOTTLE, PLASTIC (70518-2973-2) 90 tablet2021-06-090000-00-00NoNoCurrent
70518-2973-37051829730390 in 1 BOTTLE, PLASTICHistorical