FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
53217-239
11-digit product format
532170239
Labeler code
53217
Product ID
53217-239_cf46ce00-c9e1-4dc6-bc2b-03e21126b849
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA071524
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53217-239IInactivated by FDA2026-07-31
excluded packagepackage53217-23953217-239-28IInactivated by FDA2026-07-31
excluded packagepackage53217-23953217-239-30IInactivated by FDA2026-07-31
excluded packagepackage53217-23953217-239-60IInactivated by FDA2026-07-31
excluded packagepackage53217-23953217-239-90IInactivated by FDA2026-07-31

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
A071524-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071524-001AB

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 22:54:322026-06A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071524-001AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsdf17cec9-ad5e-4e57-8572-c927c9b955e22026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.7bba99e5-4096-4fcb-8591-dc4a9bfe975e2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREb3723265-7455-c25c-e053-2a95a90a379b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b617348c-cb19-45df-b313-4ea6af6f1dda2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCe07d7ee3-776d-1fa3-e053-2a95a90a70192026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd42fd0c8-3673-4f18-a6c0-cd276bbf9fef2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ab590d8-225f-43f4-bb68-1f2c86f9a8862025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP203881a3-37d0-41dd-86c5-1e53fb7843262023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524

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
53217-239-282020-01-31C16284748780-19d75b9d0-4489-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
53217-239-302020-01-31C16284748780-19d75b9d0-4489-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
53217-239-602020-01-31C16284748780-19d75b9d0-4489-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
53217-239-902020-01-31C16284748780-19d75b9d0-4489-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-239-28Trazodone Hydrochloride28 in 1 BOTTLETABLET281
53217-239-30Trazodone Hydrochloride30 in 1 BOTTLETABLET301
53217-239-60Trazodone Hydrochloride60 in 1 BOTTLETABLET601
53217-239-90Trazodone Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-239-28EA - Each53217-239ed52dc12-bc03-4a7c-89d6-822ad4e28d1012016-12-07
53217-239-30EA - Each53217-239875d5473-e710-44f9-849a-33dd6972b9b112016-12-07
53217-239-60EA - Each53217-239132c1423-0393-41ea-b336-8bedb3ca418f12016-12-07
53217-239-90EA - Each53217-2392f6318fd-ba43-4f65-99b4-bf0d67ca85d812016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-239TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20161207_29e4012e-05bb-4aff-9f20-f0c17a06a29e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN29e4012e-05bb-4aff-9f20-f0c17a06a29e1
856373trazodone hydrochloride 100 MG Oral TabletSCD29e4012e-05bb-4aff-9f20-f0c17a06a29e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-239-285321702392828 in 1 BOTTLEHistorical
53217-239-305321702393030 in 1 BOTTLEHistorical
53217-239-605321702396060 in 1 BOTTLEHistorical
53217-239-905321702399090 in 1 BOTTLEHistorical