Trazodone Hydrochloride

Product NDC
70518-3403
11-digit product format
705183403
Labeler code
70518
Product ID
70518-3403_4ef740f6-ceb9-8e57-e063-6394a90a33c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071196
Marketing category
ANDA
Marketing start
2022-04-06
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
70518-3403-0Trazodone Hydrochloride100 in 1 BOXTABLET1008
70518-3403-1Trazodone Hydrochloride1 in 1 POUCHTABLET18
70518-3403-2Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3403TRAZODONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20241120_dc1f347e-1acb-4c06-b36e-f15fecb7ac93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNdc1f347e-1acb-4c06-b36e-f15fecb7ac938
856373trazodone hydrochloride 100 MG Oral TabletSCDdc1f347e-1acb-4c06-b36e-f15fecb7ac938

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3403-070518340300100 POUCH in 1 BOX (70518-3403-0) > 1 TABLET in 1 POUCH (70518-3403-1) 100 pouch2022-04-060000-00-00NoNoCurrent
70518-3403-1705183403011 in 1 POUCHHistorical
70518-3403-27051834030230 TABLET in 1 BLISTER PACK (70518-3403-2) 30 tablet2023-09-20NoNoCurrent