FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68387-165IInactivated by FDA2026-08-03
excluded packagepackage68387-16568387-165-30IInactivated by FDA2026-08-03
excluded packagepackage68387-16568387-165-60IInactivated by FDA2026-08-03
excluded packagepackage68387-16568387-165-90IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072192-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1989-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A072192-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A072192-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1989-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A072192-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEOxford Pharmaceuticals, LLC283c8236-9776-44cb-b7b2-1024689de7362026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072192
application number: ANDA072192

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-165-302019-10-29C16284748780-1960f7f55-d286-8e05-e053-dbdaa90a074aTRAZODONE HYDROCHLORIDE TABLETS, USP
68387-165-602019-10-29C16284748780-1960f7f55-d286-8e05-e053-dbdaa90a074aTRAZODONE HYDROCHLORIDE TABLETS, USP
68387-165-902019-10-29C16284748780-1960f7f55-d286-8e05-e053-dbdaa90a074aTRAZODONE HYDROCHLORIDE TABLETS, USP

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2

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