FDA.reportPublic FDA data

Application 071523

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL50MGNoNo

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
ndc (product): 0615-8371
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREb3723265-7455-c25c-e053-2a95a90a379b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
ndc (product): 42291-868
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
ndc (product): 50111-560
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LPf6c3fb84-5b68-4675-a853-fe49bfbf3f9f2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 119 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-1118Trazodone HydrochlorideTrazodone HydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
0615-2578Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2578Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-2578Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2578Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2578Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2578Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8371Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8371Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8371Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8371Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-534Trazodone HydrochlorideTrazodone HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-133Trazodone HydrochlorideTrazodoneRebel Distributors Corp.ANDACurrent
24236-128Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
33261-107Trazodone HydrochlorideTrazodone HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
42291-833Trazodone HydrochlorideTrazodone HydrochlorideAvKARE, Inc.ANDACurrent
42291-833Trazodone HydrochlorideTrazodone HydrochlorideAvKARE, Inc.ANDACurrent
42291-833Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-833Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-833Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-868Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-868Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
43353-973Trazodone HydrochlorideTrazodone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
49999-343Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-343Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-343Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-343Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-343Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1561Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-1561Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-1561Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-1561Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-433Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-560Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-560Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-560Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-560Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-560Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-560Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-560Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50436-4715Trazodone HydrochlorideTrazodone HydrochlorideUnit Dose ServicesANDACurrent
51655-634TRAZODONETRAZODONENorthwind Pharmaceuticals, LLCANDACurrent
51655-634TrazodoneTrazodoneNorthwind Pharmaceuticals, LLCANDACurrent
53002-1132Trazodone HydrochlorideTrazodone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1132Trazodone HydrochlorideTrazodone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3132Trazodone HydrochlorideTrazodone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55045-1715Trazodone HydrochlorideTrazodone HydrochlorideDispensing Solutions, Inc.ANDACurrent
55289-064Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-064Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-064Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-064Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-064Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-064Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
58118-0429Trazodone HydrochlorideTrazodone HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0429Trazodone HydrochlorideTrazodone HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0429Trazodone HydrochlorideTrazodone HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
61919-231TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEDirect_RxANDACurrent
61919-231TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEDirect_RxANDACurrent
61919-232TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEDIRECT RXANDACurrent
61919-232TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEDIRECT RXANDACurrent
61919-912TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEDIRECT RXANDACurrent
61919-912TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEDIRECT RXANDACurrent
63187-086Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
63187-086Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
63187-086Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
64725-0433Trazodone HydrochlorideTrazodone HydrochlorideTYA PharmaceuticalsANDACurrent
66116-402Trazodone HydrochlorideTrazodone HydrochlorideMedVantx, Inc.ANDACurrent
66267-205Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-205Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66336-620Trazodone HydrochlorideTrazodone HydrochlorideDispensing Solutions, Inc.ANDACurrent