FDA.reportPublic FDA data

Application 071525

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL150MGNoNo

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
A071525-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071525-001AB

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 22:54:322026-06A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071525-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs310c4b81-d2cf-4014-873d-e71d036105de2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
ndc (product): 0615-8339
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREa382ac4d-9ab9-796a-e053-2a95a90a2c262026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
ndc (product): 42291-829
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9b022ae9-dd52-43ae-804b-ddf8e7cfd5302025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
ndc (product): 72789-079
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
ndc (product): 50111-450

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8155Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8155Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8339Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8339TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8339TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8339Trazodone HydrochlorideTrazodone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8339TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-533Trazodone HydrochlorideTrazodone HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-135Trazodone HydrochlorideTrazodoneRebel Distributors Corp.ANDACurrent
33261-386Trazodone HydrochlorideTrazodone HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
42291-829Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-829Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
42291-835Trazodone HydrochlorideTrazodone HydrochlorideAvKARE, Inc.ANDACurrent
42291-835Trazodone HydrochlorideTrazodone HydrochlorideAvKARE, Inc.ANDACurrent
42291-835Trazodone HydrochlorideTrazodone HydrochlorideAvKAREANDACurrent
49999-913Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-913Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-913Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-913Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0463Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-441Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-450Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
55289-060Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
55289-060Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-060Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-060Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
61919-585TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEDirect RxANDACurrent
61919-585TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEDirect RxANDACurrent
63629-2867Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-6334Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-6334Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
68151-2696Trazodone HydrochlorideTrazodone HydrochlorideCarilion Materials ManagementANDACurrent
68788-9341Trazodone HydrochlorideTrazodone HydrochloridePreferred PharmaceuticalsANDACurrent
70518-1441Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1441Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1441Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2793Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2793Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2793Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
72789-079Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-079Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-079Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-079Trazodone HydrochlorideTrazodone HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent