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 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-093f01610625f2…
2019-09-15 20:21 UTC2019-09A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071525-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071525-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071525-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071525-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071525-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071525-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071525-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071525-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071525-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071525-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071525-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071525-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071525-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071525-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071525-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071525-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071525-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071525-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071525-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071525-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071525-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071525-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071525-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071525-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071525-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071525-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071525-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071525-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071525-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071525-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071525-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071525-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071525-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071525-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071525-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071525-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071525-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071525-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071525-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071525-001AB1e64feba35796…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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