FDA.reportPublic FDA data

Application 071524

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL100MGNoNo

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
ndc (product): 0615-8386
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
ndc (product): 42291-869
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
ndc (product): 50111-561
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP203881a3-37d0-41dd-86c5-1e53fb7843262023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-2579Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2579Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-2579Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2579Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2579Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2579Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8386Trazodone Hydrochloridetrazodone hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8386Trazodone Hydrochloridetrazodone hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8386Trazodone Hydrochloridetrazodone hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-532Trazodone HydrochlorideTrazodone HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-134Trazodone HydrochlorideTrazodoneRebel Distributors Corp.ANDACurrent
33261-385Trazodone HydrochlorideTrazodone HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
42291-834Trazodone HydrochlorideTrazodone HydrochlorideAvKARE, Inc.ANDACurrent
42291-834Trazodone HydrochlorideTrazodone HydrochlorideAvKARE, Inc.ANDACurrent
42291-834Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-834Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-834Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-869Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-869Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
43353-974Trazodone HydrochlorideTrazodone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
49999-156Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-156Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-156Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-156Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-2462Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2462Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2462Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2462Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2462Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-434Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-561Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-561Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-561Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-561Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-561Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-561Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50436-4688Trazodone HydrochlorideTrazodone HydrochlorideUnit Dose ServicesANDACurrent
51655-986Trazodone HydrochlorideTrazodone HydrochlorideNorthwind PharmaceuticalsANDACurrent
53002-1105Trazodone HydrochlorideTrazodone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1105Trazodone HydrochlorideTrazodone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53217-239Trazodone HydrochlorideTrazodone HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
55154-0659Trazodone HydrochlorideTrazodone HydrochlorideCardinal HealthANDACurrent
55289-223Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-223Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-223Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-223Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-223Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-223Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-223Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
63187-133Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
63187-133Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
63187-133Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
63629-3210Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-3210Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-3210Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
64725-0434Trazodone HydrochlorideTrazodone HydrochlorideTYA PharmaceuticalsANDACurrent
67046-741Trazodone HydrochlorideTrazodone HydrochlorideContract Pharmacy Services-PAANDACurrent
68071-3124Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3124Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-9860Trazodone HydrochlorideTrazodone HydrochloridePreferred Pharmaceuticals, IncANDACurrent
68788-9860Trazodone HydrochlorideTrazodone HydrochloridePreferred PharmaceuticalsANDACurrent
70518-0847Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0847Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0847Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0847Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0847Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1489Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1489Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1489Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent