FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
66116-357
11-digit product format
661160357
Labeler code
66116
Product ID
66116-357_9426f88d-2f3f-4dc9-ba17-f4bc0be91963
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA073137
Marketing category
ANDA
Marketing start
1993-03-24
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66116-357IInactivated by FDA2026-07-31
excluded packagepackage66116-35766116-357-30IInactivated 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073137-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24
A073137-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24
A073137-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A073137-001AB
A073137-002AB
A073137-003AB

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 22:54:322026-06A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24a50c72e98297…
2026-08-01 22:54:322026-06A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24a50c72e98297…
2026-08-01 22:54:322026-06A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A073137-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A073137-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A073137-003AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC55f18806-6c23-783b-e063-6294a90acc462026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC4c4ca53e-9201-298c-e063-6294a90a72c62026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.fa7afa93-b98c-4dc7-bbb8-ab6a058427b92025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.f291b905-a739-5e43-e053-2995a90ac40c2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137

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
66116-357-302019-11-27C16284748780-19855d018-dd57-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use TRAZODONE safely and effectively. See full prescribing information for TRAZODONE. TRAZODONE hydrochloride tablets, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-357-30Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Trazodone HydrochlorideACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
TrazodoneACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
crospovidoneINACTIVE INGREDIENT68401960MKTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-357TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130822_9426f88d-2f3f-4dc9-ba17-f4bc0be91963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN9426f88d-2f3f-4dc9-ba17-f4bc0be919631
856377trazodone hydrochloride 50 MG Oral TabletSCD9426f88d-2f3f-4dc9-ba17-f4bc0be919631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-357-306611603573030 in 1 BOTTLE, PLASTICHistorical