FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
51655-986
11-digit product format
516550986
Labeler code
51655
Product ID
51655-986_4a92b7c1-d0ac-e368-e063-6394a90a7c67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA071524
Marketing category
ANDA
Marketing start
2022-05-18
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
ndc (product): 51655-986
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

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6E8ZO8LRNMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856373Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e07d7ee3-776d-1fa3-e053-2a95a90a7019Available on FDA.report

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
51655-986-262026-01-29C16284748780-149896155-af9c-586f-e063-e6dba90add90These 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
51655-986-522026-01-29C16284748780-149896155-af9c-586f-e063-e6dba90add90These 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
51655-986-26Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET903
51655-986-52Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-986TRAZODONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 2 package rows20231219_e07d7ee3-776d-1fa3-e053-2a95a90a7019.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNe07d7ee3-776d-1fa3-e053-2a95a90a70193
856373trazodone hydrochloride 100 MG Oral TabletSCDe07d7ee3-776d-1fa3-e053-2a95a90a70193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-986-265165509862690 TABLET in 1 BOTTLE, PLASTIC (51655-986-26) 90 tablet2022-05-180000-00-00NoNoCurrent
51655-986-525165509865230 TABLET in 1 BOTTLE, PLASTIC (51655-986-52) 30 tablet2022-05-180000-00-00NoNoCurrent