FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
43353-652
11-digit product format
433530652
Labeler code
43353
Product ID
43353-652_79266f41-f728-4daa-9c57-b2a5f3881e17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA072192
Marketing category
ANDA
Marketing start
2010-05-30
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
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-652IInactivated by FDA2026-08-03
excluded packagepackage43353-65243353-652-15IInactivated by FDA2026-08-03
excluded packagepackage43353-65243353-652-30IInactivated by FDA2026-08-03
excluded packagepackage43353-65243353-652-45IInactivated by FDA2026-08-03
excluded packagepackage43353-65243353-652-53IInactivated by FDA2026-08-03
excluded packagepackage43353-65243353-652-60IInactivated by FDA2026-08-03
excluded packagepackage43353-65243353-652-70IInactivated 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
43353-652-152020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-652-302020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-652-452020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-652-532020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-652-602020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-652-702020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-652-15Trazodone Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED151
43353-652-30Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
43353-652-45Trazodone Hydrochloride45 in 1 BOTTLE, PLASTICTABLET, FILM COATED451
43353-652-53Trazodone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
43353-652-60Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901
43353-652-70Trazodone Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-652-15EA - Each43353-6524dca6aa7-6b7d-455d-b9a4-a49cbf37e55512014-06-03
43353-652-30EA - Each43353-652b7623f74-1151-4268-a106-a5d0a5e1b8e412014-06-03
43353-652-45EA - Each43353-652f246875d-4d99-4f82-a33a-285d47d8b3d412014-06-03
43353-652-53EA - Each43353-6524ac1ca66-566d-496e-a8e9-f116b86eac5b12014-06-03
43353-652-60EA - Each43353-652e8c87137-7f3f-4e38-93d5-671a3ba1da8f12014-06-03
43353-652-70EA - Each43353-652c498164d-cc67-470b-b104-a3045853ed6a12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-652TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 6 package rows20140513_26d30297-fda9-45a4-b94a-a9f401705818.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN26d30297-fda9-45a4-b94a-a9f4017058181
856377traZODone HCl 50 MG Oral TabletPSN26d30297-fda9-45a4-b94a-a9f4017058181
856373trazodone hydrochloride 100 MG Oral TabletSCD26d30297-fda9-45a4-b94a-a9f4017058181
856377trazodone hydrochloride 50 MG Oral TabletSCD26d30297-fda9-45a4-b94a-a9f4017058181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-652-154335306521515 in 1 BOTTLE, PLASTICHistorical
43353-652-304335306523030 in 1 BOTTLE, PLASTICHistorical
43353-652-454335306524545 in 1 BOTTLE, PLASTICHistorical
43353-652-534335306525360 in 1 BOTTLE, PLASTICHistorical
43353-652-604335306526090 in 1 BOTTLE, PLASTICHistorical
43353-652-7043353065270120 in 1 BOTTLE, PLASTICHistorical