Trazodone Hydrochloride

Product NDC
68387-165
11-digit product format
683870165
Labeler code
68387
Product ID
68387-165_698b68f2-a474-4a72-a3b4-54bcc4a1d9bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA072192
Marketing category
ANDA
Marketing start
2010-11-17
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-165-30Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
68387-165-60Trazodone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
68387-165-90Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-165-30EA - Each68387-1654316ecd4-9772-42ec-b17f-1b25d8c3b76e12013-02-13
68387-165-60EA - Each68387-165de6fedac-bfe0-4c7d-894f-90f663559e3e12012-07-24
68387-165-90EA - Each68387-16598dac1f5-5b8e-402b-b2bb-322b483c04bf12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-165TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2Legacy NDC, 3 package rows20101223_911802e4-2aeb-4447-99ae-6029cdd2d7dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN911802e4-2aeb-4447-99ae-6029cdd2d7dd2
856377traZODone HCl 50 MG Oral TabletPSN911802e4-2aeb-4447-99ae-6029cdd2d7dd2
856373trazodone hydrochloride 100 MG Oral TabletSCD911802e4-2aeb-4447-99ae-6029cdd2d7dd2
856377trazodone hydrochloride 50 MG Oral TabletSCD911802e4-2aeb-4447-99ae-6029cdd2d7dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-165-306838701653030 in 1 BOTTLE, PLASTICHistorical
68387-165-606838701656060 in 1 BOTTLE, PLASTICHistorical
68387-165-906838701659090 in 1 BOTTLE, PLASTICHistorical