FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
61919-386
Requested package NDC
61919-386-90
11-digit product format
619190386
Labeler code
61919
Product ID
61919-386_875b4218-beb7-c7c2-e053-2995a90a897b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAZODONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA072192
Marketing category
ANDA
Marketing start
2019-04-25
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-38661919-386-90IInactivated 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
61919-386-902025-01-31C16284748780-11030e365-3aa2-111a-e063-dadaa90a10e2TRAZODONE HYDROCHLORIDE
61919-386-902024-01-30C16284748780-11030e365-3aa2-111a-e063-dadaa90a10e2TRAZODONE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-386-90TRAZODONE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-386TRAZODONE HYDROCHLORIDE TABLET TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20190425_66da652a-72b4-c17f-e053-2a91aa0a8d69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN66da652a-72b4-c17f-e053-2a91aa0a8d693
856377traZODone HCl 50 MG Oral TabletPSN66da652a-72b4-c17f-e053-2a91aa0a8d693
856364trazodone hydrochloride 150 MG Oral TabletSCD66da652a-72b4-c17f-e053-2a91aa0a8d693
856377trazodone hydrochloride 50 MG Oral TabletSCD66da652a-72b4-c17f-e053-2a91aa0a8d693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-386-906191903869090 TABLET, FILM COATED in 1 BOTTLE (61919-386-90) 2019-04-250000-00-00NoNoCurrent