FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
53002-4105
Requested package NDC
53002-4105-0
11-digit product format
530024105
Labeler code
53002
Product ID
53002-4105_0a824675-ed1f-4af2-a1fc-7a31003ded4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA202180
Marketing category
ANDA
Marketing start
2013-11-27
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
2023-12-31
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 packagepackage53002-410553002-4105-0IInactivated 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202180-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27
A202180-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27
A202180-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27
A202180-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A202180-001AB
A202180-002AB
A202180-003AB
A202180-004AB

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 22:54:322026-06A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27a50c72e98297…
2026-08-01 22:54:322026-06A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27a50c72e98297…
2026-08-01 22:54:322026-06A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27a50c72e98297…
2026-08-01 22:54:322026-06A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202180-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202180-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202180-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202180-004AB1a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.1f74b23d-f2eb-4c18-a583-d608b77136942026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.acd077db-e2b8-4d29-94c0-128439050c662026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETorrent Pharmaceuticals Limited1510cf89-a2ec-4ed5-80cb-bae84f9ec0a72026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf98b1e8f-9c66-3e9c-e053-6294a90ab0572025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.f7e6a78e-7ac3-35b9-e053-6294a90aabd02025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepackadc7427e-3553-4805-b063-eeda840490292025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fc9b90d1-7da5-efc1-e053-6294a90a02232025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29ac7183-e574-506e-e063-6394a90a77c92024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutionsbe0dc037-d30a-4f07-ab7c-1695637b37402024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepacka71063f9-cdc6-46bc-9eb4-626f288e46d92024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HCLTRAZODONE HCLDirect_Rx1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c2024-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEMedsource Pharmaceuticals138fef7b-db83-88c4-e063-6394a90ab0ac2024-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP3c8c3d2b-9108-40fa-90d9-6ed545cf65492023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP2a1d0989-6ed5-4a2f-bd03-73d61eb402322022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180

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
53002-4105-02025-01-30C16284748780-12cef2736-9e3a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use trazodone hydrochloride tablets, USP safely and effectively. See full prescribing information for trazodone hydrochloride tablets, USP. TRAZODONE HYDROCHLORIDE TABLETS USP, for oral use Initial U.S. Approval: 1981
53002-4105-32025-01-30C16284748780-12cef2736-9e3a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use trazodone hydrochloride tablets, USP safely and effectively. See full prescribing information for trazodone hydrochloride tablets, USP. TRAZODONE HYDROCHLORIDE TABLETS USP, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4105-0Trazodone Hydrochloride100 in 1 BOTTLETABLET1001
53002-4105-3Trazodone Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4105TRAZODONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20220331_c2a5ef88-143a-4426-ae04-af540c3a75fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNc2a5ef88-143a-4426-ae04-af540c3a75fb1
856373trazodone hydrochloride 100 MG Oral TabletSCDc2a5ef88-143a-4426-ae04-af540c3a75fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4105-053002410500100 TABLET in 1 BOTTLE (53002-4105-0) 100 tablet2021-01-010000-00-00NoNoCurrent