FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
43353-973
11-digit product format
433530973
Labeler code
43353
Product ID
43353-973_80bec5c1-751e-453c-b882-3dd39f349ef5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071523
Marketing category
ANDA
Marketing start
2014-02-06
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
2020-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-973DDiscontinued by firm2026-07-31
excluded packagepackage43353-97343353-973-15DDiscontinued by firm2026-07-31
excluded packagepackage43353-97343353-973-30DDiscontinued by firm2026-07-31
excluded packagepackage43353-97343353-973-45DDiscontinued by firm2026-07-31
excluded packagepackage43353-97343353-973-53DDiscontinued by firm2026-07-31
excluded packagepackage43353-97343353-973-70DDiscontinued by firm2026-07-31

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
A071523-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / 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
A071523-001AB

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 22:54:322026-06A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071523-001AB1a50c72e98297…

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 HYDROCHLORIDEUnit Dose Solutions, Inc.562fdfb9-c060-63bc-e063-6294a90ad8402026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.38e9820a-6edc-4bf5-b5e4-034b9e48b5832026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs310c4b81-d2cf-4014-873d-e71d036105de2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREb3723265-7455-c25c-e053-2a95a90a379b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCf2f2290f-b53c-3b38-e053-2995a90a157d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd42fd0c8-3673-4f18-a6c0-cd276bbf9fef2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ab590d8-225f-43f4-bb68-1f2c86f9a8862025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LPf6c3fb84-5b68-4675-a853-fe49bfbf3f9f2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-973-15EA - Each43353-9736fb1ad32-dfa0-492f-8471-3608c8628fca12016-07-19
43353-973-30EA - Each43353-9735d1a0a1f-ff0f-4025-a663-25883384880912016-07-19
43353-973-45EA - Each43353-9738049b7cb-9830-4604-834a-470c06a01ac012016-07-19
43353-973-53EA - Each43353-973b2ad8fc7-39b3-4357-8edd-49fec38a3e9312016-07-19
43353-973-70EA - Each43353-973b7c1497e-2a05-4932-8397-9aa8f7f1710212016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-973TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160708_48ff193c-27e1-4e1f-bd38-4ea30b6323d1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-973-154335309731515 TABLET in 1 BOTTLE (43353-973-15) 15 tablet2014-12-030000-00-00NoNoCurrent
43353-973-304335309733030 TABLET in 1 BOTTLE (43353-973-30) 30 tablet2014-10-280000-00-00NoNoCurrent
43353-973-454335309734545 TABLET in 1 BOTTLE (43353-973-45) 45 tablet2014-11-210000-00-00NoNoCurrent
43353-973-534335309735360 TABLET in 1 BOTTLE (43353-973-53) 60 tablet2014-10-140000-00-00NoNoCurrent
43353-973-7043353097370120 TABLET in 1 BOTTLE (43353-973-70) 120 tablet2014-11-210000-00-00NoNoCurrent